FDAFDA · Food and drugs·Recall number Z-2736-2017
CS 100i Intra-Aortic Balloon Pump
Published August 2, 2017 · Recall initiated: June 16, 2017
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
The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient death due to the failure of the device to initiate therapy.
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- Maquet Datascope Corp - Cardiac Assist Division
- Distributor
- Worldwide Distribution - (in over 100 countries) US (Nationwide)
- Lot
- 0998-UC-0446HXX 0998-UC-0479HXX
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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