Recall archive / FDA device enforcement
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, ... — FDA record Z-1229-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 7, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 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, 0998-UC-0800-31, 0998-UC-0800-33, 0998-UC-0800-52, 0998-UC-0800-53, and 0998-00-0800-55
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Datascope Corp.
- Quantity
- 8909 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1229-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | All Serial Numbers. Model Number: 0998-00-0800-31, UDI-DI:10607567109053; Model Number: 0998-00-0800-32, UDI-DI: 10607567111117; Model Number: 0998-00-0800-33, UDI-DI: 10607567109008; Model Number: 0998-00-0800-34, UDI-DI: 10607567111940; Model Number: 0998-00-0800-35, UDI-DI: 10607567109107; Model Number: 0998-00-0800-45, UDI-DI: 10607567108421; Model Number: 0998-00-0800-52, UDI-DI: 10607567108438; Model Number: 0998-00-0800-53, UDI-DI: 10607567108391; Model Number: 0998-00-0800-55, UDI-DI: 10607567108414; Model Number: 0998-00-0800-65, UDI-DI: 10607567113432 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide. Global Distribution.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Mar 15, 2023
- Recall initiation date
- Feb 7, 2023
- Center classification date
- Mar 6, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.