Back in early October we reported the UK recall of Edwards Lifesciences’ Embol-X Glide Protection system, here. Somewhat ironically the device, intended to filter out emboli, was deemed to be at risk of tip separation, a potential source of an embolus. Now the US FDA has issued its own Class I recall, which can be found here.
The EMBOL-X access device system is intended to capture material such as blood clots or tissue fragments during short-term cardiopulmonary bypass surgery when surgeons may need to introduce and remove devices into the vascular system.
The US FDA has issued a Class I recall notice, its highest classification, to healthcare professionals. The recall notice confirms that Edwards Lifesciences LLC has issued the recall of the EMBOL-X Glide Protection System because of a perceived risk of tip separation.
The problem was picked up through Edwards’ own complaint investigation which identified a potential health risk to patients undergoing cardio pulmonary by-pass surgery when using the system. It seems the company has identified a deformation of the cannula tip, and while that may not in itself pose a problem, it does introduce, according to Edwards, the possibility of unusual forces being applied to this tip which may lead to its separation, with the serious consequences that would bring.
Significantly, no patient injury has been reported, but the company has decided that the potential risk of injury was sufficient to warrant a recall. FDA clearly agrees.
The recall includes model numbers EXGF24D, EXGF24LLD, EXGF24MMD, EXGF24SSD, EXGF24XLD, EXGF24XSD, EXGFXS2D, EXGF24SS2D, EXGF24MM2D, EXGF24LL2D and EXGF24XL2D.
Edwards Lifesciences is recalling all lot numbers of the EMBOL-X Glide Protection System Cannulae that have not expired.
Customers are being asked to quarantine and refrain from using the affected devices and to contact Edwards Lifesciences to arrange for their return.
Source: US FDA