# K163542: CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case

- Pathway: 510(k) (Special)
- Applicant: Datascope Corp.
- Decided: Jan 31, 2017 after 46 days
- Product code: DSP (System, Balloon, Intra-Aortic And Control)
- Device class: 2
- Regulation: 21 CFR 870.3535
- Recalls of this device: 14 (7 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K892222 (1990). 65 ancestors in all.
No later device cites it as a predicate yet.
11 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151254: CARDIOSAVE Hybrid Intra-Aortic Balloon Pump, Datascope Corp. (2015) Summary page 4.

## Recalls of this device
- Nov 4, 2025 · Class II · Z-0917-2026: 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-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.

## 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/K163542
Methodology: https://510kreport.com/methodology