Reported May 3, 2023 · Ongoing
MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32
Datascope Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Datascope Corp. · 1300 Macarthur Blvd · Mahwah, NJ · 07430-2052
Is this the product you have?
- MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32
- Lot codes and dates
- UDI-DI10607567111117
- Serial Numbers
CB343612K1CB351306D2CB360094J2CB351302D2CB343613K1CB359782J2CB359780J2CB320625E0CH207880C5CB359783J2CB328500J0CB356765G2CB356763G2CB314092J9CB355433F2CB355432F2CB351305D2CB311676I9CB355435F2CB319727D0CB319726D0CB342653J1CB307113G9CB360092J2CH245699K6CB307117G9CB360095J2CB351303D2CB320623E0CB320621E0CB320620E0CB311677I9CB314093J9CB356761G2CB351307D2CB329943K0CB360093J2CB307111G9CB343611K1CB307114G9CB320624E0CB351301D2CB359781J2CB351304D2CB356762G2CB355434F2CB322068F0CB342652J1CB311675I9CB320622E0CB355431F2CB314094J9CB307112G9CB307119G9
- Amount recalled
- 54 units
Why it was recalled
The power cord supplied (Type J plug end) for the Cardiosave Hybrid IABP to Brazil is incompatible with the Brazilian Type N power receptacle.
This product could cause temporary or reversible health problems — stop using it.
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