Reported May 28, 2014 · Terminated
Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump. The Intra-Aortic Balloon Pump (IABP) is…
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?
- Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump. The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons in cardiovascular procedures.
- Lot codes and dates
- IABP Model Numbers System 98 0998-00-0446-xx 0998-UC-0446-xx System
98XT0998-00-0479-xx0998-UC-0479-xxCS100i0998-UC-0446Hxx0998-UC-0479HxxCS1000998-00-3013-xx0998-UC-3013-xxCS3000998-00-3023-xx0998-UC-3023-xx
- IABP Model Numbers System 98 0998-00-0446-xx 0998-UC-0446-xx System
- Amount recalled
- 11,881 units (US 5183 and OUS 6698)
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Potential mechanical failure of the fan assembly associated with the power supply. A fan assembly failure could result in the power supply overheating and cause the IABP to shut down without warning.
Using this product could cause serious injury, illness or death — stop using it now.
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