Abbott Vascular has initiated a voluntary safety notice for a product with instructions for use that may be unclear.
The announcement applies to Abbott's MitraClip Delivery System, a device used to treat people with degenerative mitral regurgitation (DMR), a condition involving a dysfunction of the heart's mitral valve. The company has received nine reports indicating that users are unable to separate the implantable clip from the delivery system.
An investigation conducted by Abbott determined that the delivery system's "arm positioner" was not returned to the required neutral position by the operator during the deployment sequence, subsequently preventing the clip from detaching.
All of these cases (0.17 percent incidence) resulted in surgical interventions to remove the delivery system or replace the mitral valve. The company expects that any future similar incidents would also require surgery to correct the problem.
MitraClip Delivery Systems with lot number 50714U1 and greater are affected by this recall.
There has been one patient death recorded as a result of the subsequent surgery.
Currently, there are about 3,500 of the recalled devices on the market, with about 1,300 of these in use in the United States.
Customers with questions or concerns should contact their Abbott Vascular Representative or contact the company at (800) 227-9902.