FDA Recalls FindrWIRZ Guidewire System Due to Coating Separation Issue

The U.S. Food and Drug Administration (FDA) has issued a class I recall for SentreHeart’s FindrWIRZ Guidewire System due to a coating separation issue. Used for minimally invasive procedures in the cerebrovascular, cardiovascular and peripheral vascular systems to assist with catheter insertion, the polytetrafluoroethylene coating may separate from the packaging and move elsewhere in the body. Attributed to either device design or manufacturing issues, this flaw could result in the dangerous exposure of wire beneath the coating, potentially leading to serious injury. Devices with Lot Numbers 01160568, 02160586 and 07160639 -150, distributed between June 1 – Sept. 26, 2016 and manufactured between Jan. 4 – July 22, 2016 are subject to the recall.

Read the FDA announcement.

Keywords: Drug Packaging, Equipment Design, Polytetrafluoroethylene, Product Packaging

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