FDA Enforcement
Class II
Ongoing
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
Recall: Z-2615-2021
·
Reported October 6, 2021
Enforcement
- Recall Number
- Z-2615-2021
- Event ID
- 88664
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Datascope Corp.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- N/A
- Report Date
- October 6, 2021
- Initiation Date
- September 8, 2021
- Classification Date
- September 30, 2021
- Address
- 1300 Macarthur Blvd, N/A, Mahwah, NJ, 07430-2052, United States
Description
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
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 Info
All lots
Distribution
Nationwide domestic distribution. Foreign distribution worldwide.
Quantity
3969 total (US), 3550 total (OUS)