Cardiosave Hybrid Intra-Aortic Balloon Pump. Model Numbers: D998-00-0800-31, D998-00-0800-32, D998-00-0800-33, D998-00-0800-35, D998-00-0800-36, D998-00-0800-45, D998-00-0800-52, D998-00-0800-53, D998-00-0800-55, D998-00-0800-65, D998-00-0800-83, D998-UC-0800-31, D998-UC-0800-33, D998-UC-0800-52, D998-UC-0800-53, D998-UC-0800-55.
Enforcement
- Recall Number
- Z-1231-2023
- Event ID
- 91642
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Datascope Corp.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 15, 2023
- Initiation Date
- February 7, 2023
- Classification Date
- March 6, 2023
- Address
- 1300 Macarthur Blvd, Mahwah, NJ, 07430-2052, United States
Description
Cardiosave Hybrid Intra-Aortic Balloon Pump. Model Numbers: D998-00-0800-31, D998-00-0800-32, D998-00-0800-33, D998-00-0800-35, D998-00-0800-36, D998-00-0800-45, D998-00-0800-52, D998-00-0800-53, D998-00-0800-55, D998-00-0800-65, D998-00-0800-83, D998-UC-0800-31, D998-UC-0800-33, D998-UC-0800-52, D998-UC-0800-53, D998-UC-0800-55.
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 be interrupted.
Model Number (UDI-DI): D998-00-0800-31 (10607567109053¿), D998-00-0800-32 (10607567111117), D998-00-0800-33 (10607567109008), D998-00-0800-35 (10607567109107), D998-00-0800-36 (10607567114187), D998-00-0800-45 (10607567108421), D998-00-0800-52 (10607567108438), D998-00-0800-53 (10607567108391), D998-00-0800-55 (10607567108414), D998-00-0800-65 (10607567113432), D998-00-0800-83 (10607567108407), D998-UC-0800-31 (10607567109053), D998-UC-0800-33 (10607567109008), D998-UC-0800-52 (10607567108438), D998-UC-0800-53 (10607567108391), D998-UC-0800-55 (10607567108414). All serial numbers
Nationwide US distribution. Worldwide international distribution.
11,792 units (5.408 US, 6,384 OUS)