FDA: Class I recall of SentreHeart’s FindrWIRZ Guidewire System

Editor's Note

The Food and Drug Administration (FDA) on November 22 categorized the recall by SentreHeart (Redwood City, California) of its FindrWIRZ Guidewire System as Class I, the most serious.

The recall was initiated because the PTFE coating may separate from the packaging and potentially cause serious injuries to patients. The system is used during minimally invasive cerebrovascular, cardiovascular, and peripheral vascular procedures.

The recall affects Lot Numbers 01160568, 02160586, and 07160639 -150, which were distributed between June 1 and September 26, 2016, and manufactured between January 4 and July 22, 2016.

Posted 11/22/2016] AUDIENCE: Surgery, Cardiology, Neurology, Risk Manager ISSUE: 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.