Datascope Corp.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000015587 FEI 1000222374
Datascope Corp. is a medical device manufacturer based in the United States, with 1,015 devices listed in 4 registries (FDA Class II, I and III; EU Class I) and 155 FDA recalls as of 13 Nov 2026.
- Devices
- 1,015
- Registrations
- EUDAMEDFDA
- FDA recalls
- 15564 ongoing since 2021 (87 open in total)
Registry facts
- Registries
- FDA GUDID 877
- FDA 510(k) 136
- EUDAMED 22
- FDA PMA 1
- Device classes
- FDA Class II 990
- EU Class I 13
- FDA Class I 4
- FDA Class III 1
- Top EMDN categories
- FDA recalls
- Sites and related companies
- MAQUET Critical Care AB authorised representative
- Identifiers
- EUDAMED SRN US-MF-000015587
- FDA FEI 1000222374
- DUNS 001660786
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI, FDA recalls
- Authorised rep.
- MAQUET Critical Care ABSE
What Datascope Corp. makes
Datascope Corp. manufactures cardiopulmonary bypass system blood tubing sets, intra-aortic balloon catheters, intra-aortic balloon pumps, vascular catheter introduction sets, reusable electrical-only medical device connection cables, reusable electrocardiographic lead sets, intravascular catheter adaptors, and battery boxes.
The company's devices are classified as Class II medical devices and are listed in the FDA UDI registry; Datascope Corp. is based in the United States.
Catalogue
Search and filter all 1,015 devicesShowing 1-50 of 1,015
Company details
- EUDAMED SRN
- US-MF-000015587
- FDA FEI number
- 1000222374
- DUNS number
- 001660786
- EUDAMED status
- Active
- EUDAMED registered name
- Datascope Corp
- Registered address
- 1300, MacArthur Boulevard, 07430, Mahwah, United States
- Website
- www.getinge.com
- Phone
- 18886278383
- PRRC contact
- Elliott Jang
FDA recalls
FDA recall records list 155 recalls initiated by Datascope Corp., the earliest on 2003-03-21 and the most recent on 2026-02-06. By recorded status: 87 ongoing and 68 terminated. The reasons filed fall into these groups: labeling or instructions for use, software or firmware, packaging, electrical or power, mechanical integrity, performance or accuracy and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 33
- 2018 3
- 2019 11
- 2020 17
- 2021 9
- 2022 6
- 2023 37
- 2024 5
- 2025 4
- 2026 3
2026
- 6 Feb 2026 Z-1587-2026 Class III Ongoing 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.
Full distribution text
- 23 Jan 2026 Z-1486-2026 Class II Ongoing The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
Full distribution text
- 23 Jan 2026 Z-1487-2026 Class II Ongoing The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
Full distribution text
- 6 Feb 2026 Z-1587-2026 Class III Ongoing 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.
2025
- 4 Nov 2025 Z-0916-2026 Class II Ongoing The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
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- 4 Nov 2025 Z-0917-2026 Class II Ongoing The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
Full distribution text
- 23 Oct 2025 Z-0931-2026 Class III Ongoing The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
Full distribution text
- 23 Oct 2025 Z-0932-2026 Class III Ongoing The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
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- 4 Nov 2025 Z-0916-2026 Class II Ongoing The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
2024
- 17 Sep 2024 Z-0311-2025 Class II Ongoing There is discrepant labeling on the inner and outer packaging of the device.
Full distribution text
- 8 Aug 2024 Z-3134-2024 Class I Ongoing 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.
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- 8 Aug 2024 Z-3135-2024 Class I Ongoing 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.
Full distribution text
- 17 Sep 2024 Z-0311-2025 Class II Ongoing There is discrepant labeling on the inner and outer packaging of the device.
Show the 25 most recent of 155 recalls
2024
- 8 Aug 2024 Z-3136-2024 Class I Ongoing 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.
Full distribution text
- 8 Aug 2024 Z-3137-2024 Class I Ongoing 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.
Full distribution text
- 8 Aug 2024 Z-3136-2024 Class I Ongoing 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.
2023
- 31 Jul 2023 Z-2431-2023 Class I Ongoing 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.
- 31 Jul 2023 Z-2432-2023 Class I Ongoing 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.
- 31 Jul 2023 Z-2433-2023 Class I Ongoing Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Cardiosave system entering Standby mode.
- 31 Jul 2023 Z-2434-2023 Class I Ongoing Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Cardiosave system entering Standby mode.
- 31 Jul 2023 Z-2435-2023 Class I Ongoing 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.
- 31 Jul 2023 Z-2436-2023 Class I Ongoing 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.
- 31 Jul 2023 Z-2437-2023 Class I Ongoing Users were identifying autofill failure conditions on the devices causing pump stops.
- 31 Jul 2023 Z-2438-2023 Class I Ongoing Users were identifying autofill failure conditions on the devices causing pump stops.
- 31 Jul 2023 Z-2486-2023 Class II Ongoing Users were experiencing a failure in the IAB Fiber Optic Sensor input on the IABP when inserting the Intra-Aortic Balloon Fiber Optic connector.
- 31 Jul 2023 Z-2487-2023 Class II Ongoing Users were experiencing a failure in the IAB Fiber Optic Sensor input on the IABP when inserting the Intra-Aortic Balloon Fiber Optic connector.
- 23 Jun 2023 Z-2216-2023 Class II Ongoing 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.
- 23 Jun 2023 Z-2217-2023 Class II Ongoing 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.
- 23 Jun 2023 Z-2218-2023 Class II Ongoing 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.
Frequently asked questions
How many devices does Datascope Corp. have in the registry?
The registry currently lists 1015 devices for Datascope Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Datascope Corp.'s devices?
Among its 50 most recently registered devices, Datascope Corp. has devices listed in EUDAMED (2 devices) and FDA GUDID (49 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Datascope Corp.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Datascope Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Datascope Corp.?
FDA recall records list 155 recalls initiated by Datascope Corp., the most recent initiated on 6 Feb 2026. 87 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Datascope Corp. in the registry?
The most recently registered devices listed for Datascope Corp. include Transport Protective Cover, ECC Large Pack BEQ-TOP 5221, ECC Quadrox iD 3/8 BEQ-TOP 22600 and Aurora Saint Luke's Accessory Wye BEQ-T 32201.