Z-1230-2023 Class II Ongoing
FDA device recall Z-1230-2023 was initiated by Datascope Corp. on February 7, 2023 and is designated Class II. Reason for recall: There have been reported failures of the high pressure helium regulator, which may cause a helium leak in the Cardiosave Hospital Cart. In instance of helium regulator failure, a Pump Console s inter… The recall status is ongoing. Affected quantity: 8909 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 15, 2023
- Initiation Date
- February 7, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8909 units
Product Description
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85
Reason for Recall
There have been reported failures of the high pressure helium regulator, which may cause a helium leak in the Cardiosave Hospital Cart. In instance of helium regulator failure, a Pump Console s internal reservoir of helium will not be replenished when docked into an impacted Hospital Cart. This may result in an insufficient amount of helium within the internal reservoir.
Distribution Pattern
US Nationwide. Global Distribution.
Code Information
All Serial Numbers. Model Number: 0998-00-0800-75, UDI-DI: 10607567112312; Model Number: 0998-00-0800-83, UDI-DI: 10607567108407; Model Number: 0998-00-0800-85, UDI-DI: 10607567113449