Reported Apr 6, 2016 · Terminated
Cardiosave Hybrid and rescue IABP
Maquet Datascope Corp. - Cardiac Assist Division
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: Maquet Datascope Corp - Cardiac Assist Division · 1300 MacArthur Blvd. · Mahwah, NJ · 07430-2052
Is this the product you have?
- Cardiosave Hybrid and rescue IABP
- Lot codes and dates
- Cardiosave Hybrid IABP 0998-00-0800-53,0998-UC-0800-53, Cardiosave Rescue IABP 0998-00-0800-83 & 0998-UC-0800-83
- Amount recalled
- 1243 units US; 1107 units OUS
Where it was sold
- Nationwide
- PR
Why it was recalled
Maquet has recieved information that in some Cardiosave IABPS, the scroll compressor did not meet the specifications for output pressure or vacuum at specific flow rates.
This product could cause temporary or reversible health problems — stop using it.
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