FDAFDA · Food and drugs·Recall number Z-1523-2014
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.
Published May 28, 2014 · Recall initiated: March 21, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Maquet Datascope Corp - Cardiac Assist Division
- Distributor
- Worldwide Distribution - USA (nationwide) and approximately 104 countries.
- Lot
- IABP Model Numbers System 98 0998-00-0446-xx 0998-UC-0446-xx System 98XT 0998-00-0479-xx 0998-UC-0479-xx CS100i 0998-UC-0446Hxx 0998-UC-0479Hxx CS100 0998-00-3013-xx 0998-UC-3013-xx CS300 0998-00-3023-xx 0998-UC-3023-xx
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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