Myriad-LX Light Source-for delivery of light to the surgical field to enhance visualization of ti...

FDA Device Recall #Z-1840-2021 — Class II — April 30, 2021

Recall Summary

Recall Number Z-1840-2021
Classification Class II — Moderate risk
Date Initiated April 30, 2021
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Nico Corp.
Location Indianapolis, IN
Product Type Devices
Quantity 80 units

Product Description

Myriad-LX Light Source-for delivery of light to the surgical field to enhance visualization of tissue during resection Part Number NN-7013 The Myriad-LX light source is a high-intensity 300W Xenon illuminator with a touch screen and digital dimming controls. The source is fitted with a proprietary connector to ensure usage is reserved for the Myriad-LX Illumination Fiber.

Reason for Recall

(1) Updated IFU for the LX Illumination Packs: Warning - Avoid contact between the distal opening of the delivery sleeve and tissue/debris within the surgical.field to prevent complete occlusion. Some surgical approaches (e.g., endonasal) may increase this potential. {f unintended reduction in light output occurs and/or occlusion of the sleeve is suspected, both the delivery sleeve and the fiber should be replaced (2) Removal for the LX Light Source potential for the distal tip of the sleeve/fiber assembly potential to burn healthy tissue resulting in minor to moderate injury to the patient or end user.

Distribution Pattern

US Nationwide Distribution

Lot / Code Information

Serial Numbers 350-00194D 350-00355D 350-00356D 350-00357D 350-00376D through 350-00444D 350-00451D through 350-00460D 350-00463D through 350-00467D 350-004710 through 350-00475D

Other Recalls from Nico Corp.

Recall # Classification Product Date
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
Z-2201-2012 Class II 13.5 mm x 60 mm BrainPath Sheath The NICO Br... Jul 17, 2012

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.