The Recall Desk
LowFDA (Devices)·Z-0328-2017·Announced 2016-11-16

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.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The agency classified this as a Class I recall, which is defined as unlikely to cause adverse health consequences. The source text describes a coating defect but does not report any injuries, illnesses, or deaths.

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

Distributed in 15 states:

Related recalls

Same hazard · coating defect

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