Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
FindrWIRZ Guidewire System Catalog# 40-05 Cardiology: The system is intended Recalled by SentreHeart Inc Due to A complaint was received on September 27th, 2016...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact SentreHeart Inc directly.
Affected Products
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.
Quantity: 132 worldwide distribution (98) of those units in US
Why Was This 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.
Where Was This Sold?
This product was distributed to 15 states: AZ, CA, CT, GA, IL, KS, MD, MI, MO, NE, NH, NY, OR, PA, TX
About SentreHeart Inc
SentreHeart Inc has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report