Recall archive / FDA device enforcement
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX — FDA record Z-1907-2023
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 May 4, 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 Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX
- Reason
- The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 incorrectly annotated compliance to standard 60601-1-12:2014 within the updated IFU.
- Classification
- Class III
- Recalling firm
- Datascope Corp.
- Quantity
- 4 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1907-2023
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 | UDI-DI: 10607567108414; Serial Numbers: CB286971I8 CB283804G8 CB283867G8 CB283522G8 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
International distribution in the country of Germany.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Jun 21, 2023
- Recall initiation date
- May 4, 2023
- Center classification date
- Jun 14, 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.