Reported Jun 6, 2018 · Ongoing
CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP), Part Number 0998-00-0800-XX & 0998-UC-0800-XX (excluding…
Maquet Datascope Corp. - Cardiac Assist Division
High riskUsing this product could cause serious injury, illness or death — stop using it now.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 Intra-Aortic Balloon Pump (IABP), Part Number 0998-00-0800-XX & 0998-UC-0800-XX (excluding 0998-00-0800-83, 0998-UC-0800-83 & 0998-00-0800-75) and cart 0997-00-1179
- Lot codes and dates
- All Serial Numbers distributed from 03/06/2012 to 04/26/2018
- Amount recalled
- 4300
Where it was sold
Why it was recalled
Stop using this product now
Ingress of fluids into the device can affect various electronic circuit boards which would prevent initiation or continuation of therapy.
Using this product could cause serious injury, illness or death — stop using it now.
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