FDA: Class I Recall for FindrWIRZ Guidewire System
The US Food and Drug Administration (FDA) is alerting physicians to what it has categorized as a Class I recall of the FindrWIRZ Guidewire System used during cerebrovascular, cardiovascular, and peripheral vascular procedures.
The device manufacturer, SentreHeart, initiated a recall of the system after discovering that its polytetrafluoroethylene (PTFE) coating may separate from the packaging, potentially causing serious injuries. “Separation” is defined as peeling, flaking, shedding, delamination, and sloughing off of the PTFE coating.
According to the FDA notice, SentreHeart sent an urgent medical device voluntary recall letter on September 29, 2016, telling operators to stop using the product and to return any systems to the manufacturer. The action applies to specific lot numbers, distribution dates, and manufacturing dates spelled out in the FDA’s recall notice. According to the agency, 98 devices have been recalled.
US Food and Drug Administration. SentreHeart recalls FindrWIRZ Guidewire System due to coating separation. http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm530336.htm. Published on: November 22, 2016. Accessed on: November 22, 2016.