Edwards Lifesciences has issued a recall of the guide sheath for its Pascal transcatheter mitral valve repair system, due to possible damage to the sheath’s inner lining as a result of a manufacturing issue.
The company issued an urgent field notice for the sheath, emphasising that the recall does not affect the whole valve repair system. The damage is said to have occurred in 1 out of 200 units, or about 0.5 per cent, as per the recall notice.
Physicians have been instructed not to use the guide sheaths and to return them to Edwards immediately. Edwards has said it will assist in the product’s return and replacement. The transcatheter device is just beginning to roll out across Europe and is being enrolled in US clinical trials.
Edwards said that no injuries in patients had been caused, but that embolization could occur in a segment of the liner material if the device were to be used. The company, however, said that there was nothing to suggest that previously implanted patients could be affected.
Customers have been urged to review the safety notice, but Edwards have said that no follow-up is necessary for patients and added that it has notified the relevant regulatory authorities.