Device product
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65
Z-2615-2021
Product summary
- Firm
- Datascope Corp.
- Event
- Event 88664
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3969 total (US), 3550 total (OUS)
- Official record key
device-enforcement:Z-2615-2021
Official wording
Reason: 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.
Code information: All lots
Distribution pattern: Nationwide domestic distribution. Foreign distribution worldwide.
Derived failure modes
-
Unknown
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.