Florida medical device maker Vycor Medical got the FDA’s highest risk status for a recall of its Viewsite brain access systems after the company found "an unidentified black fiber" on a device.
Vycor recalled a single lot of a single model of the Viewsite devices, which are designed to provide surgeons access to brain tissue and provide a working channel during procedures.
The FDA gave the recall a Class I designation, a label reserved for the most "serious" recalls and those in which "there is a reasonable probability that use of these products will cause serious adverse health consequences or death."
The company called customers and asked them to quarantine affected products until further notice, according to the FDA notice.
There are about 3,000 Viewsite devices in distribution, and the products are on the market in the U.S. and Japan, according to an enforcement report. The recall affects devices manufactured on May 29, 2011, and distributed between June 8-July 9, 2012.