The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2200-2012·Announced 2012-08-22

Nico BrainPath Sheaths Recalled for Incorrect Length Labeling

Nico Corp. is recalling 20 BrainPath sheaths because 50mm units were mislabeled as 60mm, creating a risk of improper fit during use.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source describes a labeling error resulting in an improper fit without reporting specific injuries or illnesses, fitting the criteria for a moderate severity recall.

Plain-English summary

Nico Corp. is recalling 20 units of the 13.5 mm x 50 mm BrainPath Sheath. The recall involves four boxes, each containing five devices. The specific lot number is 80344-TD00214, manufactured on April 11, 2012. These devices were distributed worldwide, including in the United States (specifically Michigan) and Canada.

The recall was initiated because the sheaths were mislabeled. Units that actually measure 50mm were labeled as 60mm. This discrepancy between the label and the actual physical length of the sheath can result in an improper fit when the device is used. The error was discovered on June 29, 2012, during a clinical case.

The BrainPath system consists of reusable obturators and single-patient-use disposable sheaths that are assembled in the operating room. The sheath is designed to provide access to neurological tissues. Because the length callout on the label does not match the actual length of the sheath, there is a risk that the device may not fit properly as intended.

The recalled product

Product
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…
Manufacturer
Nico Corp.
Category
Medical Device — Neurological Access Device
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

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

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 2 recalled by Nico Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Nico Corp.

See all →

Same hazard · mis labeling

See all →

Similar recalls