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.

Recall Insight

This FDA Devices action (record #Z-2200-2012) was formally reported on August 22, 2012, with the manufacturer initiating the action on July 17, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Nico Corp. is listed as the recalling firm, operating out of Indianapolis, IN. Federal records list the affected scope as 20 devices (4 boxes, 5 devices per box).

The documented reason for this recall is: 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 f… Distribution data in the federal record shows the product reached: Worldwide Distribution - USA including MI and Canada. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.