FDA regulators put their highest-risk label on a recall of Edwards Lifesciences’ (NYSE:EW) EMBOL-X Glide Protection System Cannulae, warning that reports of deformed cannula tips may be a major risk to patients.
Edwards recalled a slew of EMBOL-X devices, which are used to help capture debris such as tissue fragments and blood clots during cardiopulmonary bypass surgery, after finding deformations that the FDA says may cause patient harm or death.
The affected devices were manufactured from September 2010 through July 2013 and distributed from September 2010 through August 2013, according to the FDA notice.
Edwards has asked its customers to immediately quarantine and return all damaged cannulae, including those packaged with kits.
The recall was 1st noted overseas, initially affecting
nearly 40 lots, all unused lots of the EMBOL-X device that had not yet expired, according to an urgent field safety notice issued to Edwards customers. The defect was discovered during investigation of a customer complaint, Edwards said. No patients were reportedly harmed by the issue, but there is a risk that the deformed tips may separate and embolize if force is applied to the top during device insertion or removal.
