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Guidewire System Recalled Due to Coating Separation; Possible Embolism, Stroke Injury


On November 22, 2016, SentreHeart recalled the FindrWIRZ Guidewire System because the coating may separate (e.g., peel, flake, shed, delaminate, slough off) from the packaging and potentially cause serious injuries to patients.

 

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 made of polytetrafluoroethylene (PTFE) to reduce friction between the device and blood vessels.

 

Small pieces of the PTFE 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.

 

Coating separation may be caused by issues with the device design or manufacturing processes. The recalled product is labeled with Lot Numbers 01160568, 02160586, 07160639 -150. The recalled product was manufactured between January 4, 2016, and July 22, 2016, and distributed between June 1, 2016, and September 26, 2016.

 

The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.

 

See the FDA Safety Alert

 

Also see the recall

 

See also Medical Law Perspectives, September 2016 Report: Stroke: Challenges, Risks, and Liability Issues

 

See also Medical Law Perspectives, February 2015 Report: Mending a Broken Heart: Malpractice Risks in Diagnosing and Treating Heart Disease

 

See also Medical Law Perspectives, February 2014 Report: Congenital Heart Conditions: How Infants, Adults, and Healthcare Providers Handle the Risks

 

See also Medical Law Perspectives, December 2013 Report: Thicker Than Water: Liability When Blood Clots Cause Injury or Death

 

See also Medical Law Perspectives, November 2013 Report: Diagnosis and Treatment of Heart Attacks: Liability Issues 

 

 

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