Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
13.5 mm x 50 mm BrainPath Sheath The NICO BrainPath Recalled by Nico Corp. Due to Mislabeling
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Nico Corp. directly.
Affected Products
13.5 mm x 50 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.
Quantity: 20 devices (4 boxes, 5 devices per box)
Why Was This Recalled?
BrainPath sheaths were mislabeled. Sheaths which measure 50mm were labeled as 60mm. The length callout on the label does not match the actual length of the sheath within the packaging resulting in an improper fit as further explained below. This mislabeling was discovered on 29-June-2012 during a clinical case.
Where Was This Sold?
This product was distributed to 1 state: MI
About Nico Corp.
Nico Corp. has 7 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report