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
    • 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
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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:58 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.