Boston Scientific Recalls StarMedTec LightTrail Reusable Fibers for Laser Compatibility
Boston Scientific is recalling 5 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 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 text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity rating.
Plain-English summary
Boston Scientific Corporation is recalling 5 units of StarMedTec LightTrail Reusable Fibers, 365 um (Material/Part Number: 6453, Batch Code: 2011-00238). The recall was initiated because the product 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. The recall is classified as Class II by the U.S. Food and Drug Administration.
Healthcare providers and consumers should stop using the affected fibers and contact Boston Scientific Corporation for further instructions or a return.
The recalled product
- Product
- StarMedTec LightTrail¿ Reusable Fibers, 365 um; Material/Part Number: 6453
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Laser Fiber
- Hazard
- Affected units
- 5
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)
- Material/Part Number: 6453 Batch Code: 2011-00238
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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