Vycor Viewsite Brain Access System (VBAS): Class 1 Recall – Unidentified Fiber Found on Device | Regulatory Doctor
AUDIENCE: Neurology, Surgery, Risk Managers
ISSUE: Vycor Medical recalled its VBAS because an unidentified black fiber was found on the device. This product may cause serious adverse health consequences, including death.
BACKGROUND: The Vycor Medical Viewsite Brain Access System serves as a self-retaining retractor system for brain tissue and provides access to allow the surgeon to see the surgical site during brain and spinal procedures.
RECOMMENDATION: Vycor Medical called their customers requesting that they place products of Model # TC171105, Lot # VM83450 into quarantine until further notice. Vycor Medical asked customers holding the affected lot numbers to call the company immediately. Customers in immediate need of the product should advise the Vycor customer service team who can assist in providing an alternative product.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report Online: http://www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[01/30/2013 – Recall Notice – FDA]
REGULATORY DOCTOR 