FindrWIRZ Guidewire System by SentreHeart: Class I Recall - Coating Separation

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. Lot Numbers 01160568, 02160586, 07160639 -150, distributed between June 1, 2016 - September 26, 2016 and manufactured between January 4, 2016 - July 22, 2016 are affected.

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.

BACKGROUND: 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.

RECOMMENDATION: 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 customerservice@sentreheart.com as directed by the Urgent Medical Device Voluntary Recall letter sent to all affected customers by SentreHeart on September 29, 2016.

Health care professionals and consumers with questions are instructed to contact SentreHeart at (650)-241-6008 with any questions related to this recall.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safe3ty alert, including a link to the recall notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm530413.htm