The UK’s regulatory authority, the MHRA has listed a Field Safety Notice issued by Edwards Lifesciences in late September. It seems the company has identified incidences of a deformed tip of the cannula that is part of the EMBOL-X Glide Protection System, representing a potential health risk to patients undergoing cardio pulmonary bypass surgery.
It’s indeed ironic that a filter designed to capture particulate matter and prevent embolic complications, should itself become an embolus risk factor, but that’s what’s happened to Edwards Lifesciences’ intra-aortic filtration device.
Through its own complaint investigation, Edwards Lifesciences has identified a potential health risk to patients undergoing cardio pulmonary by-pass surgery when using the EMBOL-X Glide Protection System. While no patient injury has been reported, the company decided that the potential risk of injury in the event of tip separation was sufficient to provoke a recall of all unused, in-date affected lot numbers. Details can be found on Edwards’ Field Safety Notice, here.
The Field Safety Notice, issued on September 24th, asked all customers who had received affected product to review their inventory and quarantine affected materials for return to Edwards Lifesciences in the UK.
At the present time the FDA has not issued a similar notice.