SentreHeart Inc recalls FindrWIRZ Guidewire System Catalog# 40-05 Cardiology: The system is intended for use in the cardiovascular system for i…

Recall date

September 29, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0328-2017

FDA classification

Class I

Brand / firm

SentreHeart Inc

Sold / distributed

Worldwide Distribution - US including MO, CA, OR, GA. NH, NY, MI, TX, MD, PA, IL, KS, NE, CT, AZ and Internationally to United Kingdom and Germany

Why it was recalled

A complaint was received on September 27th, 2016 at a medical center in Germany for delamination and flaking of the PTFE lubricious coating on three FindrWIRZ Guidewire System .025 guidewires removed from their packaging hoops.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

FindrWIRZ Guidewire System Catalog# 40-05 Cardiology: The system is intended for use in the cardiovascular system for introduction and positioning of over the-wire catheters and therapeutic devices during interventional procedures.