Class 1 Recall: SentreHeart Recalls FindrWIRZ Guidewire System due to Coating Separation
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
FindrWIRZ Guidewire System
Lot Numbers: 01160568, 02160586, (no products shipped from this lot) 07160639 -150
Distribution Dates: June 1, 2016 to September 26, 2016
Manufacturing Dates: January 4, 2016 to July 22, 2016
Devices Recalled in the U.S.: 98
The FindrWIRZ Guidewire System is intended for use during minimally invasive procedures in the cerebrovascular, cardiovascular and peripheral vascular systems. The system helps the positioning of over-the-wire catheters through the insertion of a thin flexible tube into arteries of the leg or wrist. This device has a hydrophilic lubricious coating, polytetrafluoroethylene (PTFE), to reduce friction between the device and blood vessels.
Reason for Recall
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.
Who May be Affected
Health care providers using this device during vascular procedures
All patient groups undergoing procedures involving the FindrWIRZ Guidewire System
What to Do
On September 29, 2016, SentreHeart sent an Urgent Medical Device Voluntary Recall letter to all affected customers. The letter asked customers to:
Identify and stop using the affected products
Return the affected products to SentreHEART immediately
Complete and return the response form via fax 650-354-1204 or email to email@example.com
Health care professionals and consumers with questions are instructed to contact SentreHeart at (650)-241-6008 with any questions related to this recall.
Date Recall Initiated
September 29, 2016
The FDA alerts provided by MedWrench are intended to be helpful reminders, but are not to displace the timely alerts provided by the manufacturers of the products or the FDA directly. You should always consult those services prior to making any final decisions as to the timeliness and accuracy of the FDA alerts we distribute. For more visit www.fda.gov.