CLASS II Device recall · Reported 15 Oct 2014 · FDA Enforcement Report

StarMedTec LightTrail¿ Reusable Fibers, 800 um recalled

Boston Scientific is recalling StarMedTec LightTrail¿ Reusable Fibers, 800 um, distributed in New York, Texas. The recall was initiated on 30 Sep 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesMaterial/Part Number: 6457 Batch Code: 2011-00217, 2012-00239, 2012-00249, 2012-00258
Quantity recalled33 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-0051-2015
FDA event ID
69404
Recalling firm
Boston Scientific, Marlborough, MA
Classification
Class II
Status
Terminated
Recall initiated
30 Sep 2014
FDA classified
8 Oct 2014
Reported
15 Oct 2014
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Other Reasons

Timeline

30 Sep 2014Recall initiated by company
8 Oct 2014Classified by FDA+8 days
15 Oct 2014Published in enforcement report+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Product is not cleared for use with lasers other than the Auriga XL system

Product as listed by the FDA

StarMedTec LightTrail¿ Reusable Fibers, 800 um; Material/Part Number: 6457

Where it was distributed

US Distribution including the states of NY and TX.

New YorkTexas

Questions about this recall

Is StarMedTec LightTrail¿ Reusable Fibers, 800 um recalled?

Yes. Boston Scientific recalled StarMedTec LightTrail¿ Reusable Fibers, 800 um on 30 Sep 2014. The recall is Class II and its status is Terminated. Recall number Z-0051-2015.

Why was it recalled?

Product is not cleared for use with lasers other than the Auriga XL system

Which lots are affected?

Material/Part Number: 6457 Batch Code: 2011-00217, 2012-00239, 2012-00249, 2012-00258

Where was it sold?

US Distribution including the states of NY and TX.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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