FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: StarMedTec LightTrail Reusable Fibers, 800 um; Material/Part Number: 6457
- Recall number
- Z-0051-2015
- Recalling firm
- Boston Scientific Corporation
- Product
- StarMedTec LightTrail Reusable Fibers, 800 um; Material/Part Number: 6457
- Status
- Terminated
- Initiated
- 2014-09-30
- Posted
- 2014-10-08
- Terminated
- 2014-11-26
- Reason
- Product is not cleared for use with lasers other than the Auriga XL system
- Root cause
- No Marketing Application
- Action
- Boston Scientific sent an " Urgent Medical Device Recall Removal Immediate Action Required" letter dated September 30, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The notification instructs the account to check their inventory, remove any affected product from their inventory, and contact Boston Scientific for further instructions on returns. The notification also requests the completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product in their inventory. We ask that you complete and return the Reply Verification Tracking form, included with this letter, according to the instructions on page 3, even if you no longer have inventory of the recalled lots. If you identify any of the affected lots within your inventory, please segregate it immediately and you will be contacted by Boston Scientific with additional instructions after you return your form. You will receive credit, as appropriate, for any affected product in your inventory. Fax to : Field Action Center at 1-866-213-1806. For further questions call (508) 382-9555
- Quantity
- 33 units
- Distribution
- US Distribution including the states of NY and TX.
- Lot, serial or model codes
- Material/Part Number: 6457 Batch Code: 2011-00217, 2012-00239, 2012-00249, 2012-00258
- 510(k) numbers
- ["K111475"]
- PMA numbers
- not on file
- Product code
- GEX
- Firm FEI
- 3005099803
- Firm city
- Marlborough
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28