Vycor Medical has recalled its Vycor Viewsite Brain Access System because an unidentified black fibre was found on the device. This product may cause serious adverse health consequences, including death, according to a company release.
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.
Vycor Medical has called their customers requesting that they place products of Model #TC171105, Lot #VM83450, which was distributed from 8 June to 9 July 2012, 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.
The company encourages healthcare professionals and patients to report adverse events or side effects related to the use of these products to the Food and Drug Administrations’s MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: 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.