Vycor Medical ViewSite Brain Access System 17mm/ 11mm / 5cm… — Class I medical device recall Z-0673-2013
Terminated recall by Vycor Medical, Inc., reported 2013-01-23, distributed nationwide. Vycor Medical recalled their VBAS (Vycor Viewsite Brain Access System) because an unidentified black fiber was
| Recall number | Z-0673-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vycor Medical, Inc., Boca Raton, FL, United States |
| Recall initiated | 2012-08-21 |
| Classified | 2013-01-16 |
| Reported by FDA | 2013-01-23 |
| Terminated | 2013-05-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | JP |
| Quantity | 3,000 devices |
| Lot numbers | VM83450 |
| Model numbers | TC171105 |
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.
Reason for recall
Vycor Medical recalled their VBAS (Vycor Viewsite Brain Access System) because an unidentified black fiber was found on the device.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0673-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.