Recall archive / FDA device enforcement
MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32 — FDA record Z-1462-2023
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 Apr 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
- MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32
- Reason
- The power cord supplied (Type J plug end) for the Cardiosave Hybrid IABP to Brazil is incompatible with the Brazilian Type N power receptacle.
- Classification
- Class II
- Recalling firm
- Datascope Corp.
- Quantity
- 54 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1462-2023
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: 10607567111117; Serial Numbers: CB343612K1 CB351306D2 CB360094J2 CB351302D2 CB343613K1 CB359782J2 CB359780J2 CB320625E0 CH207880C5 CB359783J2 CB328500J0 CB356765G2 CB356763G2 CB314092J9 CB355433F2 CB355432F2 CB351305D2 CB311676I9 CB355435F2 CB319727D0 CB319726D0 CB342653J1 CB307113G9 CB360092J2 CH245699K6 CB307117G9 CB360095J2 CB351303D2 CB320623E0 CB320621E0 CB320620E0 CB311677I9 CB314093J9 CB356761G2 CB351307D2 CB329943K0 CB360093J2 CB307111G9 CB343611K1 CB307114G9 CB320624E0 CB351301D2 CB359781J2 CB351304D2 CB356762G2 CB355434F2 CB322068F0 CB342652J1 CB311675I9 CB320622E0 CB355431F2 CB314094J9 CB307112G9 CB307119G9 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
International distribution in the country of Brazil.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- May 3, 2023
- Recall initiation date
- Apr 4, 2023
- Center classification date
- Apr 26, 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.