Class I — Vycor Medical, Inc.
| Recalling firm | VYCOR MEDICAL INC |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | Vycor Medical recalled their VBAS (Vycor Viewsite Brain Access System) because an unidentified black fiber was found on the device. |
| 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. |
| 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. |
| Initiated | 2012-08-21 |
| Classified | 2013-01-16 |
| Terminated | 2013-05-13 |
| Recall number | Z-0673-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Vycor Medical, Inc. (Z-0673-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/63319/
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