Boston Scientific Recalls StarMedTec LightTrail Reusable Fibers for Laser Compatibility
Boston Scientific is recalling 7 units of StarMedTec LightTrail Reusable Fibers because they are not cleared for use with lasers other than the Auriga XL system.
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 3/5 (High).
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: The recall involves a medical device used with lasers, which poses a risk of harm if used with incompatible equipment. No specific injuries or illnesses are reported in the source text, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Boston Scientific Corporation is recalling 7 units of StarMedTec LightTrail Reusable Fibers, 600 um (Material/Part Number: 6455). The recall involves specific batch codes 2012-00268 and 2013-00443.
The product is being recalled because it is not cleared for use with lasers other than the Auriga XL system. The affected units were distributed in the United States, including the states of New York and Texas.
Healthcare providers and consumers should stop using these specific fibers if they are not being used with the Auriga XL system. Users should contact Boston Scientific Corporation for further instructions regarding the return or replacement of the affected devices.
The recalled product
- Product
- StarMedTec LightTrail¿ Reusable Fibers, 600 um; Material/Part Number: 6455
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Laser Fiber
- Hazard
- Affected units
- 7
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 (2)
- Material/Part Number: 6455 Batch Code: 2012-00268
- 2013-00443
Distribution
Part of a larger recall action
This product is one of 3 recalled by Boston Scientific Corporation 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.
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