Abbott’s Clip Delivery System Recall Deemed Class 1

The FDA has classified a recall of Abbott Vascular’s MitraClip Clip delivery system as Class 1.

The recall came after reports that the clip delivery system could not be detached from the clip. There were nine reports of malfunctions, with one death related to the issue.

On Feb. 4, the company sent out a safety notice with instructions on how to use the device, according to the recall notice. The company also is providing training for providers who use the device.

Roughly 3,534 devices are on the market, according to the notice. — Anisa Jibrell