Boston Scientific voluntarily recalled all models of its Fetch 2 aspiration catheter after receiving complaints of shaft breakage during procedures to remove small blood clots from the coronary arteries.
The FDA classified the action as a Class 1 recall, although Boston Scientific said it had not received reports of patient injury or death. The recall affects all 21,155 devices on the market.
Boston Scientific said patients who previously underwent a thrombectomy procedure with the catheter were not at risk of any adverse events. When the shaft broke during the procedure, it was removed or retrieved with a snare. Patients had no further complications, according to Boston Scientific.
The catheters were manufactured between June 11, 2014, and Feb. 19, 2016. They are packaged and labeled as a Bayer Medical Care product. Boston Scientific acquired the Fetch 2 catheter portfolio from Bayer in 2014.
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.