# K181122: CARDIOSAVE Intra-Aortic Balloon Pump

- Pathway: 510(k) (Special)
- Applicant: Datascope Corp.
- Decided: May 31, 2018 after 31 days
- Product code: DSP (System, Balloon, Intra-Aortic And Control)
- Device class: 2
- Regulation: 21 CFR 870.3535
- Recalls of this device: 36 (27 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.
No later device cites it as a predicate yet.
10 of 65 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 4.

## 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.
- Aug 8, 2024 · Class I · Z-3136-2024: 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 Car
- Aug 8, 2024 · Class I · Z-3134-2024: 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 Cardios
- Aug 8, 2024 · Class I · Z-3135-2024: 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 Cardios
- Aug 8, 2024 · Class I · Z-3137-2024: 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 Car
- Jul 31, 2023 · Class I · Z-2431-2023: 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 cons
- Jul 31, 2023 · Class II · Z-2487-2023: 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 · Class I · Z-2436-2023: 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 potenti
- Jul 31, 2023 · Class I · Z-2438-2023: Users were identifying autofill failure conditions on the devices causing pump stops.
- Jul 31, 2023 · Class I · Z-2435-2023: 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 potenti
- Jul 31, 2023 · Class I · Z-2437-2023: Users were identifying autofill failure conditions on the devices causing pump stops.
- Jul 31, 2023 · Class II · Z-2486-2023: 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 · Class I · Z-2432-2023: 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 cons
- Jul 31, 2023 · Class I · Z-2434-2023: Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Cardiosave system entering Standby mode.
- Jul 31, 2023 · Class I · Z-2433-2023: Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Cardiosave system entering Standby mode.
- Jun 5, 2023 · Class I · Z-2149-2023: 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 aler
- Jun 5, 2023 · Class I · Z-2150-2023: 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 aler
- Jun 5, 2023 · Class I · Z-2151-2023: 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 · Class I · Z-2152-2023: 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.
- Feb 7, 2023 · Class I · Z-1148-2023: 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 thr
- Feb 7, 2023 · Class I · Z-1147-2023: 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 thr
- Feb 7, 2023 · Class II · Z-1231-2023: 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 
- Feb 7, 2023 · Class II · Z-1232-2023: 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 
- Dec 19, 2022 · Class I · Z-0885-2023: 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 · Class I · Z-0886-2023: 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.
- 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-0076-2022: 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-2616-2021: 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
- 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.
- Sep 20, 2018 · Class I · Z-0099-2019: There is a potential for interruption and/or inability to start therapy to the patient prior to or during use of Cardiosave IABP for users who are at altitudes above 3200 Ft.
- Sep 20, 2018 · Class I · Z-0100-2019: There is a potential for interruption and/or inability to start therapy to the patient prior to or during use of Cardiosave IABP for users who are at altitudes above 3200 Ft.

## Indications for use
The CARDIOSAVE IABP (Hybrid Model) is indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure.

Source page: https://510kreport.com/device/K181122
Methodology: https://510kreport.com/methodology