# K151254: CARDIOSAVE Hybrid Intra-Aortic Balloon Pump

- Pathway: 510(k) (Special)
- Applicant: Datascope Corp.
- Decided: Jul 2, 2015 after 51 days
- Product code: DSP (System, Balloon, Intra-Aortic And Control)
- Device class: 2
- Regulation: 21 CFR 870.3535
- Recalls of this device: 20 (12 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K892222 (1990). 64 ancestors in all.
1 later device descends from it; 1 cites it directly.
11 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112372: Cardiosave Hybrid Intra-Aortic Balloon Pump, Cardiac Assist, Maquet Cardiovascular, LLC (2011) Summary page 5.

## Most influential descendants
- 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
- 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.
- 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-1943-2019: If battery maintenance is not performed per instructions, the battery may provide less than the minimum run time of operating power.
- 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-1944-2019: If battery maintenance is not performed per instructions, the battery may provide less than the minimum run time of operating power.
- 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.
- Jul 17, 2017 · Class I · Z-3087-2017: False blood back detection alarm and the ingress of fluids into the IABP affecting various electronic circuit boards could potentially prevent initiation or continuation of therapy.
- Jun 16, 2017 · Class I · Z-2738-2017: The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient death due to the fai
- 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

## Indications for use
The CARDIOSAVE Intra-Aortic Balloon Pump is indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure.

Source page: https://510kreport.com/device/K151254
Methodology: https://510kreport.com/methodology