FDA Medical Device Recalls (openFDA)
Vycor Medical, Inc.: 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.
- Recall number
- Z-0673-2013
- Recalling firm
- Vycor Medical, Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2012-08-21
- Posted
- 2013-01-17
- Terminated
- 2013-05-13
- Reason
- Vycor Medical recalled their VBAS (Vycor Viewsite Brain Access System) because an unidentified black fiber was found on the device.
- Root cause
- Equipment maintenance
- Action
- Vycor Medical, Inc. notified all customers of the product recall by telephone and follow-up letter. Customers were instructed to quarantine affected products and hold the shipment(s) in quarantine unti further notice. The units will be replaced with inspected and passed units. All distributors were instructed to notify their customers of the recall and ask to have them return their stock. For question call 561-558-2020.
- Quantity
- 3000 devices
- Distribution
- Worldwide Distribution - USA (Nationwide) in the states of TX, IL, NJ, FL, OH, PA and (International) in the country of Japan.
- Lot, serial or model codes
- Model # TC171105 Lot # VM83450
- 510(k) numbers
- ["K060973"]
- PMA numbers
- not on file
- Product code
- GZT
- Firm FEI
- 3005880844
- Firm city
- Boca Raton
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28