Cardiosave Hybrid Intra-Aortic Balloon Pump

• Ongoing Z-1587-2026 FDA Class III ·initiated 6 Feb 2026

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.

• Ongoing Z-0916-2026 FDA Class II ·initiated 4 Nov 2025

The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.

2 recalls, same reason

• Ongoing Z-0931-2026 FDA Class III ·initiated 23 Oct 2025
• Ongoing Z-0932-2026 FDA Class III ·initiated 23 Oct 2025

The IFU addendum updates the Vibration and Shock Table to reference the correct standards.

• Ongoing Z-1907-2023 FDA Class III ·initiated 4 May 2023

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.

• Ongoing Z-1462-2023 FDA Class II ·initiated 4 Apr 2023

The power cord supplied (Type J plug end) for the Cardiosave Hybrid IABP to Brazil is incompatible with the Brazilian Type N power receptacle.

4 recalls, same reason

• Ongoing Z-1279-2023 FDA Class II ·initiated 28 Feb 2023
• Ongoing Z-1276-2023 FDA Class II ·initiated 28 Feb 2023
• Ongoing Z-1278-2023 FDA Class II ·initiated 28 Feb 2023
• Ongoing Z-1277-2023 FDA Class II ·initiated 28 Feb 2023

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.

2 recalls, same reason

• Ongoing Z-1146-2023 FDA Class I ·initiated 7 Feb 2023
• Ongoing Z-1145-2023 FDA Class I ·initiated 7 Feb 2023

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.

2 recalls, same reason

• Ongoing Z-1230-2023 FDA Class II ·initiated 7 Feb 2023
• Ongoing Z-1229-2023 FDA Class II ·initiated 7 Feb 2023

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.

2 recalls, same reason

• Ongoing Z-0336-2022 FDA Class I ·initiated 15 Nov 2021
• Ongoing Z-0337-2022 FDA Class I ·initiated 15 Nov 2021

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.

• Ongoing Z-0091-2022 FDA Class I ·initiated 21 Sep 2021

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.

• Ongoing Z-2615-2021 FDA Class II ·initiated 8 Sep 2021

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.

• Ongoing Z-0075-2022 FDA Class II ·initiated 8 Sep 2021

The Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in the presence of Electromagnetic Interference.

2 recalls, same reason

• Ongoing Z-1507-2021 FDA Class III ·initiated 22 Mar 2021
• Ongoing Z-1506-2021 FDA Class III ·initiated 22 Mar 2021

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).

2 recalls, same reason

• Ongoing Z-1942-2019 FDA Class I ·initiated 17 Jun 2019
• Ongoing Z-1940-2019 FDA Class I ·initiated 17 Jun 2019

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.

• Ongoing Z-1941-2019 FDA Class I ·initiated 17 Jun 2019

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.

• Ongoing Z-1939-2019 FDA Class I ·initiated 17 Jun 2019

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.

• Ongoing Z-1928-2018 FDA Class I ·initiated 3 May 2018

Ingress of fluids into the device can affect various electronic circuit boards which would prevent initiation or continuation of therapy.

• Terminated Z-1386-2017 FDA Class II ·initiated 23 Dec 2016

Maquet has received 3 confirmed complaints related to the Li-lon Battery used with the Maquet CARDIOSAVE Hybrid IABP and Maquet CARDIOSAVE Rescue IABP of the battery venting after being accidentally dropped.

• Terminated Z-1248-2016 FDA Class II ·initiated 16 Dec 2015

Maquet has recieved information that in some Cardiosave IABPS, the scroll compressor did not meet the specifications for output pressure or vacuum at specific flow rates.

• Terminated Z-1140-2015 FDA Class II ·initiated 30 Jan 2015

Power supply malfunction complaints related to suboptimal thermal management.

• Terminated Z-1062-2015 FDA Class II ·initiated 16 Dec 2014

Ferrule Cap was not removed on some fiber-optic Sensation and Sensation Plus IABC demonstration units. If fiber-optic connector is inserted into the Maquet CS300 or CARDIOSAVE IABP, cap will prevent connection of unit and may become dislodged and remain in IABPs fiber-optic receptacle.

• Terminated Z-0662-2013 FDA Class II ·initiated 27 Mar 2012

In the Cardiosave Intra-aortic Balloon Pump, there is a possibility that the coiled cord assembly, a prominent connector cord between the Cardiosave IABP housing and the dual display head which secured atop the IABP may fail as a result of mishandling.