Vycor Medical, a healthcare products manufacturer based in Florida, received Class I recall status for its Viewsite brain access systems following the detection of a foreign object.

According to a recall notice from the United States Food and Drug Administration, Vycor Medical discovered that its Viewsite brain access systems have an “unidentified black fiber” that could pose a health hazard to patients. The Viewsite brain access system is designed to give surgeons easier access to brain tissue. In addition, the device provides a work channel during surgical operations. Since the devices come in direct contact with the brain, they must remain sterile for safe use. The unidentified black fiber found on some devices could represent a bacterial or viral biohazard.

According to the notice, an FDA Class I recall indicates that "there is a reasonable probability that use of these products will cause serious adverse health consequences or death."

Vycor Medical called their customers in August 2012 requesting that they place products of Model # TC171105, Lot # VM83450 into quarantine until further notice. Vycor states that it then replaced all affected product, the distribution of which had been limited to 5 customers in the US and 2 customers internationally. This physical recall was completed in September 2012 in the US and November 2012 internationally. Vycor states that there are no longer any defective products from this lot on the market.

References

www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm337363.htm

www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Event-Detail.cfm?...