FDAApril 25, 2022device
CardioTek EP-TRACER Software V2.x.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Device did not pass electrical safety testing for adequate insulation.
What to do
FDA enforcement status: Completed
Brands named
cardiotek bvcardiotek
UPCs
0426044145541804260441455234
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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