Z-0049-2015Class II

StarMedTec LightTrail Reusable Fibers, 365 um; Material/Part Number: 6453

Name: Z-0049-2015 StarMedTec LightTrail Reusable Fibers, 365 um; Material/Part Number: 6453
Creator: Boston Scientific Corporation
Published: 2014-09-30
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2014-09-30 / Terminated

FDA source

Boston Scientific Corporation began a recall of StarMedTec LightTrail Reusable Fibers, 365 um; Material/Part Number: 6453 on 2014-09-30. FDA classified it as Class II and gives the reason as "Product is not cleared for use with lasers other than the Auriga XL system". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0049-2015
Classification: Class II
Status: Terminated
Initiated: 2014-09-30
Posted: 2014-10-08
Terminated: 2014-11-26
Recalling firm: Boston Scientific Corporation
Product: StarMedTec LightTrail Reusable Fibers, 365 um; Material/Part Number: 6453
Product code: GEX Powered Laser Surgical Instrument
Reason for recall: Product is not cleared for use with lasers other than the Auriga XL system
FDA 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 in commerce: 5 units
Distribution: US Distribution including the states of NY and TX.
Product codes and lots: Material/Part Number: 6453 Batch Code: 2011-00238

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0049-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0049-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-15	2014-10-08
Z-0050-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-15	2014-10-08
Z-0051-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-15	2014-10-08

Product code GEX

K111475Class IIAuriga XlStarmedtec GmbH / cleared 2011-09-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)