CLASS II Device recall · Reported 22 Aug 2012 · FDA Enforcement Report

BrainPath Sheath The NICO BrainPath is a family of products recalled

Nico is recalling BrainPath Sheath The NICO BrainPath is a family of products that consists of multiple, distributed in Michigan. The recall was initiated on 17 Jul 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesREF: NN-8011 - LOT: 80344-TD00214 (manufactured on 11-April-2012)

Quantity recalled20 devices (4 boxes, 5 devices per box)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2200-2012
FDA event ID: 62588
Recalling firm: Nico, Indianapolis, IN
Classification: Class II
Status: Terminated
Recall initiated: 17 Jul 2012
FDA classified: 13 Aug 2012
Reported: 22 Aug 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Other Medical Devices

Timeline

17 Jul 2012	Recall initiated by company
13 Aug 2012	Classified by FDA	+27 days
22 Aug 2012	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

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.

Where it was distributed

Worldwide Distribution - USA including MI and Canada

Michigan

Questions about this recall

Is BrainPath Sheath The NICO BrainPath is a family of products that consists of multiple recalled?

Yes. Nico recalled BrainPath Sheath The NICO BrainPath is a family of products that consists of multiple on 17 Jul 2012. The recall is Class II and its status is Terminated. Recall number Z-2200-2012.

Why was it recalled?

Which lots are affected?

REF: NN-8011 - LOT: 80344-TD00214 (manufactured on 11-April-2012)

Where was it sold?

Worldwide Distribution - USA including MI and Canada

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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