The Recall Desk
ModerateFDA (Devices)·Z-0673-2013·Announced 2013-01-23

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.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class I, which typically indicates a low probability of adverse health consequences. The hazard is an unidentified foreign material (black fiber) with no reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

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 channe
Manufacturer
Vycor Medical, Inc.
Category
Medical Device — Neurosurgical Instrument
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

Distributed nationwide across the United States.

The notice also names 6 states specifically:

Related recalls

Same hazard · foreign material

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