Vycor Medical, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0673-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Vycor Medical ViewSite Brain Access System 17mm/ 11mm / 5cm Device***STERILE*** Product Usage: The Vycor Viewsite Brain Access System (VBAS) has been designed to serve as a self-retaining retractor system for brain tissue. It is comprised of an introducer and a working channel port that are secured by a spring-loaded latch. Each device allows for the gentle retraction of tissue, visualization of the surgical site and for the smooth manipulation of introduced instruments. The range of device sizes (width and length) provides various working channel sizes.

Product Classification:

Class I

Date Initiated: August 21, 2012

Date Posted: January 23, 2013

Recall Number: Z-0673-2013

Event ID: 63319

Reason for Recall:

Vycor Medical recalled their VBAS (Vycor Viewsite Brain Access System) because an unidentified black fiber was found on the device.

Status: Terminated

Product Quantity: 3000 devices

Code Information:

Model # TC171105 Lot # VM83450

Distribution Pattern:

Worldwide Distribution - USA (Nationwide) in the states of TX, IL, NJ, FL, OH, PA and (International) in the country of Japan.

Voluntary or Mandated:

Voluntary: Firm initiated