FDAClass IJanuary 23, 2013

Vycor Medical ViewSite Brain Access System 17mm/ 11mm recall

Vycor Medical ViewSite Brain Access System 17mm/ 11mm / 5cm Device***STERILE*** Product Usage: The Vycor Viewsite Brain Access System (VBAS) has been…

Why was Vycor Medical ViewSite Brain Access System 17mm/ 11mm recalled?

Vycor Medical recalled their VBAS (Vycor Viewsite Brain Access System) because an unidentified black fiber was found on the device.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model # TC171105 Lot # VM83450

Product
Vycor Medical ViewSite Brain Access System 17mm/ 11mm / 5cm Device***STERILE*** Product Usage: The Vycor Viewsite Brain Access System (VBAS) has been…
Recalling firm
Vycor Medical, Inc.
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.
Recall date
January 23, 2013
Classification
Class I
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls