FDAJune 16, 2017device
CS 100 Intra-Aortic Balloon Pump
Official recall recorded by the U.S. Food & Drug Administration.
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
FDA enforcement status: Terminated
Brands named
maquet datascope corp cardiac assist divisionmaquetmaquet datascope
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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