13.5 mm x 50 mm BrainPath Sheath The NICO BrainPath is a family of products that consists of m...
FDA Device Recall #Z-2200-2012 — Class II — July 17, 2012
Recall Summary
| Recall Number | Z-2200-2012 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 17, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Nico Corp. |
| Location | Indianapolis, IN |
| Product Type | Devices |
| Quantity | 20 devices (4 boxes, 5 devices per box) |
Product Description
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.
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.
Distribution Pattern
Worldwide Distribution - USA including MI and Canada
Lot / Code Information
REF: NN-8011 - LOT: 80344-TD00214 (manufactured on 11-April-2012)
Other Recalls from Nico Corp.
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|---|---|---|---|
| Z-1840-2021 | Class II | Myriad-LX Light Source-for delivery of light to... | Apr 30, 2021 |
| Z-1839-2021 | Class II | NICO Myriad-LX Illumination Pack: REF: NN-1000... | Apr 30, 2021 |
| Z-2822-2018 | Class II | NICO Shepherd' s Hook - Greenberg, sterile. An ... | Jun 19, 2018 |
| Z-2767-2015 | Class II | NICO Myriad Console Model number NN-7000 T... | Jul 29, 2015 |
| Z-2045-2016 | Class II | Myriad handpiece Tissue morcellator | Feb 24, 2014 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.