Device product
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Z-2487-2023
Product summary
- Firm
- Datascope Corp.
- Event
- Event 92489
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 9379 units
- Official record key
device-enforcement:Z-2487-2023
Official wording
Reason: Users were experiencing a failure in the IAB Fiber Optic Sensor input on the IABP when inserting the Intra-Aortic Balloon Fiber Optic connector.
Code information: All Lot Numbers. Model: 0998-00-0800-75, UDI: 10607567112312; Model: 0998-00-0800-83, UDI: 10607567108407; Model: 0998-00-0800-85, UDI: 10607567113449
Distribution pattern: US Nationwide. Global Distribution.
Derived failure modes
-
Unknown
Users were experiencing a failure in the IAB Fiber Optic Sensor input on the IABP when inserting the Intra-Aortic Balloon Fiber Optic connector.