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Datascope Corp.

United States·US-MF-000015587

Last updated September 17, 2026

Information

Country: United States
Address: 1300, MacArthur Boulevard, Mahwah, United States
Website: www.getinge.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 18886278383
PRRC Contact: Elliott Jang
EUDAMED SRN: US-MF-000015587
FDA FEI Number: 1000222374
DUNS Number: 001660786

Catalogue (1014)

Page 19 of 21

Device	Model / Reference	Registries	Class	Status
Datascope Percor Stat 8.5 Fr 40cc Intra-Aortic Bal	K903892	FDA 510(k)	Class II	Active
Multinex Monitor (modification)	K883254	FDA 510(k)	Class II	Active
Rotating Hemostatic Valve	K890800	FDA 510(k)	Class II	Active
Datascope 6000 Monitor	K926099	FDA 510(k)	Class II	Active
System 97	K922235	FDA 510(k)	Class II	Active
Pressure Module (model P3)	K761017	FDA 510(k)	Class II	Active
Capnograph	K831776	FDA 510(k)	Class II	Active
Model 2000 Monitor	K812828	FDA 510(k)	Class II	Active
Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter And Cs300 Intra-Aortic Balloon Pump Control System	K063525	FDA 510(k)	Class II	Active
Netguard Automated Clinician Alert System, Model 0998-00-1600-Xx	K071805	FDA 510(k)	Class II	Active
System 90 And System 90t	K913847	FDA 510(k)	Class II	Active
Accucom 2	K874138	FDA 510(k)	Class II	Active
Spectrum Patient Monitor, Model 0998-00-0500-Xxxxx	K031849	FDA 510(k)	Class II	Active
Accutorr Plus Non Invasive Blood Pressure Monitor (0998-00-0117-Xx)	K970061	FDA 510(k)	Class II	Active
Percor Stat Dl 8.5 Fr 40cc Intra-Aortic Balloon	K911000	FDA 510(k)	Class II	Active
Physiological Monitor 2100	K844353	FDA 510(k)	Class II	Active
CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump	K172305	FDA 510(k)	Class II	Active
Datascope Interlock Guide Wire Extension	K894318	FDA 510(k)	Class II	Active
Vessel Dilator	K904476	FDA 510(k)	Class II	Active
Percor Stat-Dl 9.5 Fr.34cc & 40cc /percor Stat-Dl 10.5 Fr.40cc & 50cc Intra-Aortic Balloon Modification	K940178	FDA 510(k)	Class II	Active
Guide Wire Introducer	K890807	FDA 510(k)	Class II	Active
Datascope 10.5 French Intra-Aortic Bal	K821065	FDA 510(k)	Class II	Active
System 90 Transport	K863219	FDA 510(k)	Class II	Active
Cs100 Intra-Aortic Balloon Pump, Model 0998-00-3013-Xx	K031636	FDA 510(k)	Class II	Active
Datascope Nitinol Catheter Guide Wire (145 Cm), Datascope Nitinol Catheter Guide Wire (175 Cm), Datascope Nitinol Cathet	K001198	FDA 510(k)	Class II	Active
Percor 9.5 Fr Iab On Datascope Co2	K833828	FDA 510(k)	Class II	Active
Datascope's 8fr. Polymide 25cc, 34cc And 40cc Iab And Accessories, Models 0684-00-0327, 06844-00-0328, 0684-00-0329	K994157	FDA 510(k)	Class II	Active
Datascope Proguide Chronic Dialysis Catheter	K042016	FDA 510(k)	Class II	Active
Datascope 95 And 97 Iab Pump Console	K942454	FDA 510(k)	Class II	Active
Datascope Reinforced Percutaneous Catheter Introducer Set	K002365	FDA 510(k)	Class II	Active
Guide Wire For The Use With Datascope Percor Stat-Dl Iabs	K943896	FDA 510(k)	Class II	Active
Datascope Ptca Percutaneous Catheter Introducer	K901391	FDA 510(k)	Class II	Active
Datascope 8.5 French Electrode Intra-Aortic Balloo	K850482	FDA 510(k)	Class II	Active
Balloon Pump	K780280	FDA 510(k)	Class II	Active
2500 Printer	K860164	FDA 510(k)	N/A	Active
Model 84 Transport System	K811372	FDA 510(k)	Class II	Active
Datascope Percor Stat 9.5 Fr 40cc Intra-Aortic Bal	K903893	FDA 510(k)	Class II	Active
Coronary Guide Wire	K883579	FDA 510(k)	Class II	Active
Physiological Recorder Model 721a	K772052	FDA 510(k)	Class I	Active
Sheath Remover	K841878	FDA 510(k)	Class II	Active
Datascope Multinex Id Plus	K930303	FDA 510(k)	Class II	Active
Percor Stat Dl 9.5 Fr 34cc Intra-Aortic Balloon	K903769	FDA 510(k)	Class II	Active
Pecor 8.5 French Iab On A Datascope	K831307	FDA 510(k)	Class II	Active
Percor Stat Dl 8.5 Fr 40cc Iab Only/Labeling Chang	K902057	FDA 510(k)	Class II	Active
Percor Stat-Dl 9.5 Fr & Stat-Sl 8.5 Fr Intra-Aorti	K896430	FDA 510(k)	Class II	Active
Datascope 7.5fr. Iab Catheter And Accessories	K041281	FDA 510(k)	Class II	Active
System 96 Intra-Aortic Balloon Pump (iabp)	K965236	FDA 510(k)	Class II	Active
Trio Monitor	K051897	FDA 510(k)	Class II	Active
Accutorr Plus Non Invasive Blood Pressure Monitor, Model # 0998-00-0117-Xx	K983575	FDA 510(k)	Class II	Active
Percluder Dl Occluding Balloon	K832386	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

MAQUET Critical Care AB SE

Importers

Not available yet.

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Authorities

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FDA Recalls (100)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Feb 6, 2026	Z-1587-2026	—	open, classified	The Battery Charging Station is an optional dual-bay charger used to charge the Cardiosave IABP Lithium- Ion batteries when they are not being used to operate the IABP. Getinge has identified that a protruding screw in the left battery bay limits full insertion of certain batteries and prevents proper charging. The right bay of the Battery Charging Station is not affected by this issue.
Jan 23, 2026	Z-1486-2026	—	open, classified	The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
Jan 23, 2026	Z-1487-2026	—	open, classified	The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
Nov 4, 2025	Z-0917-2026	—	open, classified	The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
Nov 4, 2025	Z-0916-2026	—	open, classified	The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
Oct 23, 2025	Z-0931-2026	—	open, classified	The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
Oct 23, 2025	Z-0932-2026	—	open, classified	The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
Sep 17, 2024	Z-0311-2025	—	open, classified	There is discrepant labeling on the inner and outer packaging of the device.
Aug 8, 2024	Z-3134-2024	—	open, classified	Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump devices.
Aug 8, 2024	Z-3137-2024	—	open, classified	Firm has developed a software correction (Revision D.01) for outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump devices.
Aug 8, 2024	Z-3136-2024	—	open, classified	Firm has developed a software correction (Revision D.01) for outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump devices.
Aug 8, 2024	Z-3135-2024	—	open, classified	Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump devices.
Jul 31, 2023	Z-2486-2023	—	open, classified	Users were experiencing a failure in the IAB Fiber Optic Sensor input on the IABP when inserting the Intra-Aortic Balloon Fiber Optic connector.
Jul 31, 2023	Z-2437-2023	—	open, classified	Users were identifying autofill failure conditions on the devices causing pump stops.
Jul 31, 2023	Z-2435-2023	—	open, classified	Users were reporting instances of "Gas Loss in IAB Circuit" and "Gas Gain in IAB Circuit" alarms while providing therapy. An internal investigation of the complaints determined that there is a potential trigger for these alarms that was not listed in the IFU: Patient Movement (coughing, general movement, and swallowing). Blood in the circuit, kins and abrasions of the tubing/catheter and certain patient conditions could also trigger these alarms. The HHE also identified hardware issues related to these alarms.
Jul 31, 2023	Z-2431-2023	—	open, classified	Users were reporting that the device was not charging as expected. It was discovered that users were unaware that the Cardiosave console was not completely inserted into the hospital cart. If the console is not fully inserted back into the cart the battery(ies) will not charge.
Jul 31, 2023	Z-2434-2023	—	open, classified	Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Cardiosave system entering Standby mode.
Jul 31, 2023	Z-2438-2023	—	open, classified	Users were identifying autofill failure conditions on the devices causing pump stops.
Jul 31, 2023	Z-2432-2023	—	open, classified	Users were reporting that the device was not charging as expected. It was discovered that users were unaware that the Cardiosave console was not completely inserted into the hospital cart. If the console is not fully inserted back into the cart the battery(ies) will not charge.
Jul 31, 2023	Z-2487-2023	—	open, classified	Users were experiencing a failure in the IAB Fiber Optic Sensor input on the IABP when inserting the Intra-Aortic Balloon Fiber Optic connector.
Jul 31, 2023	Z-2433-2023	—	open, classified	Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Cardiosave system entering Standby mode.
Jul 31, 2023	Z-2436-2023	—	open, classified	Users were reporting instances of "Gas Loss in IAB Circuit" and "Gas Gain in IAB Circuit" alarms while providing therapy. An internal investigation of the complaints determined that there is a potential trigger for these alarms that was not listed in the IFU: Patient Movement (coughing, general movement, and swallowing). Blood in the circuit, kinks/abrasions of the tubing/catheter and certain patient conditions could also trigger these alarms. The firm's HHE also identified hardware issues related to these alarms.
Jun 23, 2023	Z-2224-2023	—	open, classified	During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending aorta, or embolization; surgical intervention and delay of IAB therapy may also result. Firm has received 10 complaints, including 3 serious adverse events and 1 patient death.
Jun 23, 2023	Z-2220-2023	—	open, classified	During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending aorta, or embolization; surgical intervention and delay of IAB therapy may also result. Firm has received 10 complaints, including 3 serious adverse events and 1 patient death.
Jun 23, 2023	Z-2218-2023	—	open, classified	During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending aorta, or embolization; surgical intervention and delay of IAB therapy may also result. Firm has received 10 complaints, including 3 serious adverse events and 1 patient death.
Jun 23, 2023	Z-2219-2023	—	open, classified	During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending aorta, or embolization; surgical intervention and delay of IAB therapy may also result. Firm has received 10 complaints, including 3 serious adverse events and 1 patient death.
Jun 23, 2023	Z-2216-2023	—	open, classified	During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending aorta, or embolization; surgical intervention and delay of IAB therapy may also result. Firm has received 10 complaints, including 3 serious adverse events and 1 patient death.
Jun 23, 2023	Z-2222-2023	—	open, classified	During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending aorta, or embolization; surgical intervention and delay of IAB therapy may also result. Firm has received 10 complaints, including 3 serious adverse events and 1 patient death.
Jun 23, 2023	Z-2217-2023	—	open, classified	During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending aorta, or embolization; surgical intervention and delay of IAB therapy may also result. Firm has received 10 complaints, including 3 serious adverse events and 1 patient death.
Jun 23, 2023	Z-2223-2023	—	open, classified	During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending aorta, or embolization; surgical intervention and delay of IAB therapy may also result. Firm has received 10 complaints, including 3 serious adverse events and 1 patient death.
Jun 23, 2023	Z-2221-2023	—	open, classified	During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending aorta, or embolization; surgical intervention and delay of IAB therapy may also result. Firm has received 10 complaints, including 3 serious adverse events and 1 patient death.
Jun 5, 2023	Z-2150-2023	—	open, classified	IABP may lose the ability to charge batteries in one or both bay slots. Therapy may be interrupted if batteries fail to charge and the device is disconnected from AC power. Low battery alarms may alert the User to the issue prior to interruption of therapy.
Jun 5, 2023	Z-2149-2023	—	open, classified	IABP may lose the ability to charge batteries in one or both bay slots. Therapy may be interrupted if batteries fail to charge and the device is disconnected from AC power. Low battery alarms may alert the User to the issue prior to interruption of therapy.
Jun 5, 2023	Z-2151-2023	—	open, classified	An unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the Power Management Board and/or Solenoid Board. This issue may lead to an unexpected interruption of therapy.
Jun 5, 2023	Z-2152-2023	—	open, classified	An unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the Power Management Board and/or Solenoid Board. This issue may lead to an unexpected interruption of therapy.
May 4, 2023	Z-1907-2023	—	open, classified	The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 incorrectly annotated compliance to standard 60601-1-12:2014 within the updated IFU.
Apr 4, 2023	Z-1462-2023	—	open, classified	The power cord supplied (Type J plug end) for the Cardiosave Hybrid IABP to Brazil is incompatible with the Brazilian Type N power receptacle.
Feb 28, 2023	Z-1279-2023	—	open, classified	There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This potential failure of an impacted Safety Disk may lead to slightly reduced IAB inflation during therapy or a reduction in the degree of augmentation provided to the patient during therapy.
Feb 28, 2023	Z-1276-2023	—	open, classified	There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This potential failure of an impacted Safety Disk may lead to slightly reduced IAB inflation during therapy or a reduction in the degree of augmentation provided to the patient during therapy.
Feb 28, 2023	Z-1277-2023	—	open, classified	There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This potential failure of an impacted Safety Disk may lead to slightly reduced IAB inflation during therapy or a reduction in the degree of augmentation provided to the patient during therapy.
Feb 28, 2023	Z-1278-2023	—	open, classified	There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This potential failure of an impacted Safety Disk may lead to slightly reduced IAB inflation during therapy or a reduction in the degree of augmentation provided to the patient during therapy.
Feb 7, 2023	Z-1148-2023	—	open, classified	An unexpected shutdown of the IABP may occur due to loss of communication between the Executive Processor PCBA and the Video Generator PCBA. This may result in an interruption to therapy which may threaten the hemodynamic stability of the supported patient as the user is left unaware to the status of the Cardiosave IABP.
Feb 7, 2023	Z-1230-2023	—	open, classified	There have been reported failures of the high pressure helium regulator, which may cause a helium leak in the Cardiosave Hospital Cart. In instance of helium regulator failure, a Pump Console s internal reservoir of helium will not be replenished when docked into an impacted Hospital Cart. This may result in an insufficient amount of helium within the internal reservoir.
Feb 7, 2023	Z-1146-2023	—	open, classified	An unexpected shutdown of the IABP may occur due to a failure of the connection between the Coiled Cord cable and the Cable Assembly backplane to the Coiled Cord cable which provides the communication between the display head and base unit.
Feb 7, 2023	Z-1145-2023	—	open, classified	An unexpected shutdown of the IABP may occur due to a failure of the connection between the Coiled Cord cable and the Cable Assembly backplane to the Coiled Cord cable which provides the communication between the display head and base unit.
Feb 7, 2023	Z-1232-2023	—	open, classified	Firm has received reports of damaged, worn, or torn O-rings on the Cardiosave Pump Console quick disconnect fitting, which results in helium tank leaks. If the helium supply is depleted, therapy will be interrupted.
Feb 7, 2023	Z-1147-2023	—	open, classified	An unexpected shutdown of the IABP may occur due to loss of communication between the Executive Processor PCBA and the Video Generator PCBA. This may result in an interruption to therapy which may threaten the hemodynamic stability of the supported patient as the user is left unaware to the status of the Cardiosave IABP.
Feb 7, 2023	Z-1229-2023	—	open, classified	There have been reported failures of the high pressure helium regulator, which may cause a helium leak in the Cardiosave Hospital Cart. In instance of helium regulator failure, a Pump Console s internal reservoir of helium will not be replenished when docked into an impacted Hospital Cart. This may result in an insufficient amount of helium within the internal reservoir.
Feb 7, 2023	Z-1231-2023	—	open, classified	Firm has received reports of damaged, worn, or torn O-rings on the Cardiosave Pump Console quick disconnect fitting, which results in helium tank leaks. If the helium supply is depleted, therapy will be interrupted.
Dec 19, 2022	Z-0886-2023	—	open, classified	The Cardiosave IABP may shut down unexpectedly due to blood entering in the Cardiosave IABP when therapy is provided with a compromised intra-aortic balloon catheter.
Dec 19, 2022	Z-0885-2023	—	open, classified	The Cardiosave IABP may shut down unexpectedly due to blood entering in the Cardiosave IABP when therapy is provided with a compromised intra-aortic balloon catheter.
Aug 5, 2022	Z-1686-2022	—	open, classified	Certain lots containing undersized dilator.
Aug 5, 2022	Z-1687-2022	—	open, classified	Certain lots containing undersized dilator.
Aug 5, 2022	Z-0131-2023	—	open, classified	The balloon volume is incorrectly described as 34cc instead of 40cc on one of the three internal labels enclosed for hospital use. A labelling error may result in user confusion and/or delay in initiating therapy. Therapy delays may impact those patients who are more hemodynamically unstable.
Aug 5, 2022	Z-1685-2022	—	open, classified	Certain lots containing undersized dilator.
Nov 15, 2021	Z-0336-2022	—	open, classified	Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the device may short various electronic components thus leading to system shutdown, which could result in unsafe hemodynamic instability.
Nov 15, 2021	Z-0337-2022	—	open, classified	Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the device may short various electronic components thus leading to system shutdown, which could result in unsafe hemodynamic instability.
Sep 21, 2021	Z-0091-2022	—	open, classified	A Cardiosave Lithium-Ion Battery Pack used during protocol testing failed to meet the minimum runtime requirement per Getinge internal Product Specification. These nonconforming batteries were inadvertently released to customers.
Sep 8, 2021	Z-2616-2021	—	open, classified	The Cardiosave IABP may unexpectedly shut down when the device is running on AC power, only one battery is installed in the IABP, and the battery is physically removed while the battery is being charged. This occurs during a very specific set of conditions.
Sep 8, 2021	Z-2615-2021	—	open, classified	The Cardiosave IABP may unexpectedly shut down when the device is running on AC power, only one battery is installed in the IABP, and the battery is physically removed while the battery is being charged. This occurs during a very specific set of conditions.
Sep 8, 2021	Z-0075-2022	—	open, classified	The Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in the presence of Electromagnetic Interference.
Sep 8, 2021	Z-0076-2022	—	open, classified	The Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in the presence of Electromagnetic Interference.
Mar 22, 2021	Z-1506-2021	—	open, classified	There are cybersecurity vulnerabilities in a widely used low-level TCP/IP software library that may result in a loss of communication to the Hospital Information System/Clinical Information System (HIS/CIS).
Mar 22, 2021	Z-1507-2021	—	open, classified	There are cybersecurity vulnerabilities in a widely used low-level TCP/IP software library that may result in a loss of communication to the Hospital Information System/Clinical Information System (HIS/CIS).
Jul 27, 2020	Z-2838-2020	—	open, classified	Potential Endotoxin Contamination
Jul 27, 2020	Z-2846-2020	—	open, classified	Potential Endotoxin Contamination
Jul 27, 2020	Z-2844-2020	—	open, classified	Potential Endotoxin Contamination
Jul 27, 2020	Z-2841-2020	—	open, classified	Potential Endotoxin Contamination
Jul 27, 2020	Z-2836-2020	—	open, classified	Potential Endotoxin Contamination
Jul 27, 2020	Z-2837-2020	—	open, classified	Potential Endotoxin Contamination
Jul 27, 2020	Z-2839-2020	—	open, classified	Potential Endotoxin Contamination
Jul 27, 2020	Z-2834-2020	—	open, classified	Potential Endotoxin Contamination
Jul 27, 2020	Z-2847-2020	—	open, classified	Potential Endotoxin Contamination
Jul 27, 2020	Z-2831-2020	—	open, classified	Potential Endotoxin Contamination
Jul 27, 2020	Z-2835-2020	—	open, classified	Potential Endotoxin Contamination
Jul 27, 2020	Z-2843-2020	—	open, classified	Potential Endotoxin Contamination
Jul 27, 2020	Z-2840-2020	—	open, classified	Potential Endotoxin Contamination
Jul 27, 2020	Z-2845-2020	—	open, classified	Potential Endotoxin Contamination
Jul 27, 2020	Z-2833-2020	—	open, classified	Potential Endotoxin Contamination
Jul 27, 2020	Z-2832-2020	—	open, classified	Potential Endotoxin Contamination
Jul 27, 2020	Z-2842-2020	—	open, classified	Potential Endotoxin Contamination
Nov 20, 2019	Z-0933-2020	—	terminated	Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer Sets Maquet 7 Fr., 7.5 Fr. and 8 Fr. IABs.
Nov 20, 2019	Z-0934-2020	—	terminated	Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer Sets Maquet 7 Fr., 7.5 Fr. and 8 Fr. IABs.
Nov 20, 2019	Z-0932-2020	—	terminated	Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer Sets Maquet 7 Fr., 7.5 Fr. and 8 Fr. IABs.
Oct 3, 2019	Z-0266-2020	—	terminated	One lot of "Low Level Output Cable - Interface to Philips Monitor" was received from the supplier with an incorrect cable in the packaging.
Jun 17, 2019	Z-1944-2019	—	open, classified	If battery maintenance is not performed per instructions, the battery may provide less than the minimum run time of operating power.
Jun 17, 2019	Z-1942-2019	—	open, classified	If battery maintenance is not performed appropriately, the battery may provide less than the minimum run time of operating power. Revised labeling and training are being provided.
Jun 17, 2019	Z-1941-2019	—	open, classified	If battery maintenance is not performed appropriately, the battery may provide less than the minimum run time of operating power. Revised labeling and training are being offered.
Jun 17, 2019	Z-1939-2019	—	open, classified	Battery short-run times and unanticipated stoppage may be due to user not performing battery maintenance and handling as needed. Inadequate labeling is being targeted for this recall, and design updates will be handled in a subsequent recall.
Jun 17, 2019	Z-1940-2019	—	open, classified	If battery maintenance is not performed appropriately, the battery may provide less than the minimum run time of operating power. Revised labeling and training are being provided.
Jun 17, 2019	Z-1943-2019	—	open, classified	If battery maintenance is not performed per instructions, the battery may provide less than the minimum run time of operating power.
May 28, 2019	Z-1966-2019	—	terminated	The device was distributed with the outer carton labeled with the manufacture date and the expiry date reversed. This showed the product as expired before it was manufactured.
Feb 21, 2018	Z-1384-2018	—	terminated	The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Contraindications section.
Feb 21, 2018	Z-1383-2018	—	terminated	The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Contraindications section.
Feb 21, 2018	Z-1385-2018	—	terminated	The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Contraindications section.
Oct 19, 2017	Z-1722-2018	—	terminated	The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow.
Oct 19, 2017	Z-1725-2018	—	terminated	The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow.
Oct 19, 2017	Z-1714-2018	—	terminated	The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow.
Oct 19, 2017	Z-1706-2018	—	terminated	The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow.
Oct 19, 2017	Z-1721-2018	—	terminated	The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow.