Reported Mar 8, 2017 · Terminated
CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is 0998-:XX-0800-XX Li-Ion Battery affected part…
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 IABP and CARDIOSAVE Rescue
- IABP affected part number is 0998-XX-0800-XX Li-Ion Battery affected part
- number is 0146-00-0097 Product UsageThe CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons
- Lot codes and dates
- part number 0146-00-0097
- Amount recalled
- 8000
Where it was sold
- Nationwide
Why it was recalled
Maquet has received 3 confirmed complaints related to the Li-lon Battery used with the Maquet CARDIOSAVE Hybrid IABP and Maquet CARDIOSAVE Rescue IABP of the battery venting after being accidentally dropped.
This product could cause temporary or reversible health problems — stop using it.
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