Boston Scientific Recalls StarMedTec LightTrail Reusable Fibers for Laser Compatibility
Boston Scientific is recalling 33 units of StarMedTec LightTrail Reusable Fibers because the product is 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 is classified as FDA Class II, and the hazard involves the use of a medical device with incompatible equipment, which poses a risk of harm even though specific injuries are not reported in the source text.
Plain-English summary
Boston Scientific Corporation is recalling 33 units of StarMedTec LightTrail Reusable Fibers, 800 um (Material/Part Number: 6457). The recall involves specific batch codes: 2011-00217, 2012-00239, 2012-00249, and 2012-00258.
The recall was initiated because the product is not cleared for use with lasers other than the Auriga XL system. The agency has classified this as a Class II recall.
The affected units were distributed in the United States, including the states of New York and Texas. Healthcare providers and facilities should stop using the affected fibers and contact Boston Scientific for instructions on return or replacement.
The recalled product
- Product
- StarMedTec LightTrail¿ Reusable Fibers, 800 um; Material/Part Number: 6457
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Laser Fibers
- Hazard
- Affected units
- 33
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 (4)
- Material/Part Number: 6457 Batch Code: 2011-00217
- 2012-00239
- 2012-00249
- 2012-00258
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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