Bay Area's SentreHEART Recalls Findrwirz Guidewire System Over Coating Separation Issues
SentreHeart is recalling a select number of its FindWIRZ guidewire systems over PTFE coating separation issues, according to an FDA release posted today.
The recall has been given a Class I label from the FDA, which indicates “a reasonable probability that use of these products will cause serious adverse health consequences or death,” according to the agency.
The FindrWIRZ guide wire system is designed for use during minimally invasive cerebrovascular, cardiovascular and peripheral vascular systems to help position over-the-wire catheters through the insertion of a thin flexible tube into arteries of the leg or wrist.
The recall has been given a Class I label from the FDA, which indicates “a reasonable probability that use of these products will cause serious adverse health consequences or death,” according to the agency.
The FindrWIRZ guide wire system is designed for use during minimally invasive cerebrovascular, cardiovascular and peripheral vascular systems to help position over-the-wire catheters through the insertion of a thin flexible tube into arteries of the leg or wrist.