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 company initiated the recall over issues with the hydrophilic lubricious PTFE coating, designed to reduce friction, separating from the wire. Coating separation could cause small pieces of the coating to break away and travel elsewhere in the body, while the exposed wire beneath could cause dangerous blood clots.
Both circumstances could lead to serious adverse health consequences, the FDA warned, including embolism, stroke or death.
A total of 98 units are affected by the recall, with lot numbers 01160568, 02160586 and 07160639 -150, manufactured between January 4, 2016 and July 22, 2016 and distributed between June 1, 2016 and September 26, 2016.
The company began notifying customers with the devices on September 29, instructing customers to identify and stop use of the devices and return them to SentreHeart.
In September, SentreHeart said that it landed a $35 million Series D round from Deerfield Management, with funds slated to support a trial evaluating its Lariat suture delivery system.
The Amaze trial aims to investigate the use of Lariat for catheter-based left atrial appendage closure in patients with persistent atrial fibrillation, the Redwood City, Calif-based company said.
The post SentreHeart recalls FindrWIRZ Guidewire System over coating separation issues appeared first on MassDevice.
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