Device Recall 13.5 mm x 60 mm BrainPath Sheath

REF: NN-8012 - LOT: 80345-TD00214 (manufactured on 11-April-2012)

Neurological Devices

2

No

Worldwide Distribution - USA including MI and Canada

13.5 mm x 60 mm BrainPath Sheath || The NICO BrainPath is a family of products that consists of multiple sized reusable and re-sterilizable obturators with coordinating single patient use, disposable sheaths (three lengths available for each: 50mm, 60mm, and 75mm). The obturator and sheath are assembled in the OR immediately prior to use. These two components are held together by an interference fit. The device when used as intended is designed to provide access to neurological tissues.