Edwards Lifesciences Recalls Pascal Guide Sheath

Edwards Lifesciences has pulled all lots of the guide sheath used with its Edwards Pascal transcatheter valve repair system.

“It has been identified that there is a potential for damage to the inner liner of the Pascal guide sheath due to a manufacturing issue,” the company said. It estimated that approximately one in 200 units, or 0.5 percent, have been affected.

No reports of injuries or adverse events have been made so far, and there are no indications that the problem affects patients previously implanted with the device, the company said.