Device Recall 13.5 mm x 60 mm BrainPath Sheath

  • Model / Serial
    REF: NN-8012 - LOT: 80345-TD00214 (manufactured on 11-April-2012)
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including MI and Canada
  • Product Description
    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.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Nico Corp., 12263 Bridgewater Rd, Indianapolis IN 46256-9428
  • Manufacturer Parent Company (2017)
  • Source
    USFDA