Vycor Medical Recalls Brain Access System Due to Black Fiber
Vycor Medical is recalling 3,000 ViewSite Brain Access System devices because an unidentified black fiber was found on the product.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Vycor Medical recalled their VBAS (Vycor Viewsite Brain Access System) because an unidentified black fiber was found on the device."
Plain-English summary
Vycor Medical, Inc. is recalling 3,000 units of the ViewSite Brain Access System (VBAS) 17mm/11mm/5cm device. The recall was initiated because an unidentified black fiber was found on the device. The product is a self-retaining retractor system designed for brain tissue, comprising an introducer and a working channel port secured by a spring-loaded latch.
The affected devices are identified by Model # TC171105 and Lot # VM83450. These devices were distributed worldwide, including nationwide in the United States (specifically in Texas, Illinois, New Jersey, Florida, Ohio, and Pennsylvania) and internationally in Japan.
The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled devices or what to do if they have already used the product. No illnesses or injuries are reported in the source text.
The recalled product
- 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…
- Manufacturer
- Vycor Medical, Inc.
- Hazard
- Affected units
- 3,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model # TC171105 Lot # VM83450
Distribution
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