Medical Device Safety and Recalls: SentreHeart Recalls FindrWIRZ Guidewire System due to Coating Separation

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: SentreHeart Recalls FindrWIRZ Guidewire System due to Coating Separation

SentreHeart is recalling the FindrWIRZ Guidewire System because the PTFE coating may separate (e.g., peel, flake, shed, delaminate, slough off) from the packaging and potentially cause serious injuries to patients. Coating separation may be caused by issues with the device design or manufacturing processes. Small pieces of the coating could break away and travel elsewhere in the body, or the exposed wire beneath the coating could cause dangerous blood clots in the patient’s bloodstream and can lead to serious adverse health consequences including embolism, stroke, or death.

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