CLASS II Device recall · Reported 27 Dec 2017 · FDA Enforcement Report

Trevo(TM) XP ProVue Procedure Pack recalled by Stryker Neurovascular

Stryker Neurovascular is recalling Trevo(TM) XP ProVue Procedure Pack, Trevo(TM) XP Provue Retriever, .Excelsior(TM), distributed nationwide in the US. The recall was initiated on 3 Nov 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number QX10100894. Exp. Date 28-Oct-18

Quantity recalled1 unit

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-0277-2018
FDA event ID: 78607
Recalling firm: Stryker Neurovascular, Fremont, CA
Classification: Class II
Status: Terminated
Recall initiated: 3 Nov 2017
FDA classified: 21 Dec 2017
Reported: 27 Dec 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

3 Nov 2017	Recall initiated by company
21 Dec 2017	Classified by FDA	+48 days
27 Dec 2017	Published in enforcement report	+6 days

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

Reason for recall

Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs were manufactured using a carton sleeve where the sleeve label contents did not match the physical contents within the pack.

Product as listed by the FDA

Trevo(TM) XP ProVue Procedure Pack, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm, .Excelsior(TM) XT-27(TM) 1 TIP STRAIGHT, 150 cm, 6 cm, Microcatheter; UPN 93068 Stroke intervention kit

Where it was distributed

International Distribution to: Germany, Slovakia and Israel.

Nationwide

Questions about this recall

Is Trevo(TM) XP ProVue Procedure Pack, Trevo(TM) XP Provue Retriever, .Excelsior(TM) recalled?

Yes. Stryker Neurovascular recalled Trevo(TM) XP ProVue Procedure Pack, Trevo(TM) XP Provue Retriever, .Excelsior(TM) on 3 Nov 2017. The recall is Class II and its status is Terminated. Recall number Z-0277-2018.

Why was it recalled?

Which lots are affected?

Lot Number QX10100894. Exp. Date 28-Oct-18

Where was it sold?

International Distribution to: Germany, Slovakia and Israel.

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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