SentreHeart voluntarily recalled its FindrWIRZ guidewire system after discovering the device’s coating could separate from the packaging and potentially cause serious injuries.
The company announced the recall in a Nov. 22 news release and said it affected 98 devices.
The system is used during minimally invasive procedures in the cardiovascular, cerebrovascular and peripheral vascular systems. The recalled devices were distributed between June 1 and Sept. 26, 2016, and those manufactured between Jan. 4 and July 22, 2016.
SentreHeart said it sent an urgent medical device voluntary recall letter to customers on Sept. 29. The company mentioned that small pieces of coating could break from the device and travel elsewhere. It also noted that exposed wire beneath the coating could cause blood clots and lead to embolism, stroke or death.
In July 2015, the FDA issued a safety alert that warned of deaths and severe adverse events associated with SentreHeart’s Lariat suture delivery device for left atrial appendage (LAA) exclusion and preventing strokes in patients with atrial fibrillation. The device is not FDA-approved for LAA closure.
SentreHeart also received $35 million in financing in September. The company said it would use the money to complete a randomized trial evaluating the Lariat device for LAA closure in patients with atrial fibrillation.
Executive Editor
Tim Casey joined TriMed Media Group in 2015 as Executive Editor. For the previous four years, he worked as an editor and writer for HMP Communications, primarily focused on covering managed care issues and reporting from medical and health care conferences. He was also a staff reporter at the Sacramento Bee for more than four years covering professional, college and high school sports. He earned his undergraduate degree in psychology from the University of Notre Dame and his MBA degree from Georgetown University.