SentreHeart Recalls FindrWIRZ Guidewire Systems Due to Coating Defects
SentreHeart Inc is recalling FindrWIRZ Guidewire Systems because the lubricious coating delaminated and flaked off three units in Germany.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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."
Plain-English summary
SentreHeart Inc is voluntarily recalling the FindrWIRZ Guidewire System, Catalog # 40-05. This medical device is intended for use in the cardiovascular system to introduce and position over-the-wire catheters and therapeutic devices during interventional procedures.
The recall was initiated after a complaint was received on September 27, 2016, at a medical center in Germany. The complaint reported delamination and flaking of the PTFE lubricious coating on three FindrWIRZ Guidewire System .025 guidewires that had been removed from their packaging hoops.
The affected lots are 01160568, 02160586, and 07160639. A total of 132 units were distributed worldwide, with 98 units distributed in the United States. The United States distribution included Missouri, California, Oregon, Georgia, New Hampshire, New York, Michigan, Texas, Maryland, Pennsylvania, Illinois, Kansas, Nebraska, and Arizona. The product was also distributed internationally to the United Kingdom and Germany. No products were shipped from Lot 02160586.
The recalled product
- Product
- 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.
- Manufacturer
- SentreHeart Inc
- Category
- Medical Device — Cardiology
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot# 01160568 . Lot#02160586
- (no products shipped from this lot) Lot# 07160639 -150
Distribution
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