Edwards Lifesciences (NYSE:EW) recalled nearly 40 lots of its EMBOL-X Glide Protection Systems after finding that some may have been shipped with deformed cannula heads that may represent a risk to patients.
The recall includes all unused lots of the EMBOL-X device that have not yet expired, according to an urgent field safety notice issued to Edwards customers.
The issue 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.
The recall was reported by healthcare regulators in the U.K. and in Hong Kong, but the warning has yet to appear in the FDA’s online database.