Z-2616-2021 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 6, 2021
- Initiation Date
- September 8, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3969 total (US); 3550 total (OUS)
Product Description
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Reason for Recall
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.
Distribution Pattern
Nationwide domestic distribution. Foreign distribution worldwide.
Code Information
All lots