# K112372: Cardiosave Hybrid Intra-Aortic Balloon Pump

- Pathway: 510(k) (Special)
- Applicant: Cardiac Assist, Maquet Cardiovascular, LLC
- Decided: Sep 15, 2011 after 29 days
- Product code: DSP (System, Balloon, Intra-Aortic And Control)
- Device class: 2
- Regulation: 21 CFR 870.3535
- Recalls of this device: 31 (10 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K892222 (1990). 63 ancestors in all.
3 later devices descend from it; 2 cite it directly.
12 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063525: Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300 Intra-Aortic Balloon Pump Control System, Datascope Corp. (2007) Summary page 1.

## Most influential descendants
- K151254: CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (2015), 1 descendant of its own
- K181122: CARDIOSAVE Intra-Aortic Balloon Pump (2018), 0 descendants of its own
- K163542: CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case (2017), 0 descendants of its own

## Recalls of this device
- Feb 6, 2026 · Class III · Z-1587-2026: 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 p
- Nov 4, 2025 · Class II · Z-0916-2026: 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 · Class III · Z-0932-2026: The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
- Oct 23, 2025 · Class III · Z-0931-2026: The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
- May 4, 2023 · Class III · Z-1907-2023: 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.
- Apr 4, 2023 · Class II · Z-1462-2023: The power cord supplied (Type J plug end) for the Cardiosave Hybrid IABP to Brazil is incompatible with the Brazilian Type N power receptacle.
- Feb 28, 2023 · Class II · Z-1278-2023: 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
- Feb 28, 2023 · Class II · Z-1279-2023: 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
- Feb 28, 2023 · Class II · Z-1277-2023: 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
- Feb 28, 2023 · Class II · Z-1276-2023: 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
- Feb 7, 2023 · Class II · Z-1230-2023: 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 intern
- Feb 7, 2023 · Class I · Z-1146-2023: 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
- Feb 7, 2023 · Class II · Z-1229-2023: 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 intern
- Feb 7, 2023 · Class I · Z-1145-2023: 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
- Nov 15, 2021 · Class I · Z-0336-2022: 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
- Nov 15, 2021 · Class I · Z-0337-2022: 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
- Sep 21, 2021 · Class I · Z-0091-2022: 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 inadver
- Sep 8, 2021 · Class II · Z-0075-2022: 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 · Class II · Z-2615-2021: 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 charg
- Mar 22, 2021 · Class III · Z-1506-2021: 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 (HI
- Mar 22, 2021 · Class III · Z-1507-2021: 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 (HI
- Jun 17, 2019 · Class I · Z-1940-2019: 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.
- Jun 17, 2019 · Class I · Z-1939-2019: 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 updat
- Jun 17, 2019 · Class I · Z-1942-2019: 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.
- Jun 17, 2019 · Class I · Z-1941-2019: 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.
- May 3, 2018 · Class I · Z-1928-2018: Ingress of fluids into the device can affect various electronic circuit boards which would prevent initiation or continuation of therapy.
- Dec 23, 2016 · Class II · Z-1386-2017: 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 d
- Dec 16, 2015 · Class II · Z-1248-2016: 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.
- Jan 30, 2015 · Class II · Z-1140-2015: Power supply malfunction complaints related to suboptimal thermal management.
- Dec 16, 2014 · Class II · Z-1062-2015: 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 c
- Mar 27, 2012 · Class II · Z-0662-2013: 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 secure

## Indications for use
The CARDIOSAVE TM Intra Aortic Balloon Pump is an electromechanical system used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation. The intra-aortic balloon is placed in the descending aorta, just distal to the left subclavian artery. Once the balloon is positioned, the pump is adjusted to trigger in synchrony with the EG or arterial pressure waveform to ensure that inflation and deflation occur at the appropriate points during the cardiac cycle. The target population is adult. The balloon pump is intended for use in the health care facility setting.

Source page: https://510kreport.com/device/K112372
Methodology: https://510kreport.com/methodology