The Recall Desk
HighFDA (Devices)·Z-1840-2021·Announced 2021-06-16

Myriad-LX Light Source Recalled Due to Burn and Occlusion Risk

Nico Corp. is recalling 80 Myriad-LX Light Source units due to potential burn injury to patients from the distal tip of the fiber assembly and risk of delivery sleeve occlusion during surgical use.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall with potential for burn injury to patients from a medical device used in invasive surgical procedures. No injuries or hospitalizations have been reported; the hazard is theoretical based on device design characteristics. This qualifies as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Nico Corp. is recalling 80 units of the Myriad-LX Light Source (Part Number NN-7013), a 300W xenon surgical illumination system used to deliver light to the surgical field during tissue resection procedures. These units were distributed nationwide; specific serial numbers are documented in the FDA recall notice.

The recall was initiated due to two identified risks. First, the distal tip of the sleeve/fiber assembly has the potential to burn healthy tissue, resulting in minor to moderate injury to patients or end users. Second, contact between the distal opening of the delivery sleeve and tissue or debris within the surgical field may cause complete occlusion of the light delivery system, reducing light output during critical surgical procedures.

Surgeons and surgical facility staff using these light sources should immediately discontinue use if they observe unintended reduction in light output or suspect occlusion of the delivery sleeve. Both the delivery sleeve and fiber should be replaced if occlusion is suspected. Affected facilities should contact Nico Corp. for guidance on replacement or device disposition.

The recalled product

Product
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 fit
Manufacturer
Nico Corp.
Category
Medical Device — Surgical Light Source
Hazard
  • burn-injury
  • occlusion

Distribution

Distributed nationwide across the United States.

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