CLASS II ONGOING Device recall · Reported 27 Jul 2022 · FDA Enforcement Report

Trevo Trak 21 Microcatheter recalled by Stryker Neurovascular

Stryker Neurovascular is recalling Trevo Trak 21 Microcatheter, distributed nationwide in the US. The recall was initiated on 3 Jun 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesREF/UDI/Lot: 90338/(01)07613327313956(17)231022(10)0000086176/0000086176; OUS: REF/Lot: 91412/46383767; 91413/46402565, 46383768, 46383779, 46383776; 91414/46383765, 46383772, 46383773, 46386864, 46383775, 46383774; 91415/46402572, 46383781, 46383771, 46383766; SFP914170/46383769; SFP914190/46383770

Quantity recalled71

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-1386-2022
FDA event ID: 90482
Recalling firm: Stryker Neurovascular, Fremont, CA
Classification: Class II
Status: Ongoing
Recall initiated: 3 Jun 2022
FDA classified: 15 Jul 2022
Reported: 27 Jul 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

3 Jun 2022	Recall initiated by company
15 Jul 2022	Classified by FDA	+42 days
27 Jul 2022	Published in enforcement report	+12 days

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

Reason for recall

Microcatheter product label on the carton is missing the microcatheter product drawing/illustration.

Product as listed by the FDA

Trevo Trak 21 Microcatheter, REF: 90338. TREVO NXT 3X32+TRAK21 2-PACK - CE, REF: 91412; TREVO NXT 4X28+TRAK21 2-PACK - CE, REF: 91413; TREVO NXT 4X41+TRAK21 2-PACK - CE, REF: 91414; TREVO NXT 6X37+TRAK21 2-PACK - CE, REF: 91415; TREVO NXT 4X28+TRAK21+CAT6 3-PACK - CE, REF: SFP914170 TREVO NXT 6X37+TRAK21+CAT6 3-PACK - CE, REF: SFP914190. Used in the placement of devices and/or fluids, such as contrast media, into the peripheral, coronary, and neuro vasculature during diagnostic and/or therapeutic procedures.

Where it was distributed

Worldwide distribution - US Nationwide distribution in the states of CA, OR, PA, NY, DC, IL, WA, NH, NJ, OK, FL, AZ, AL, GA, TX, WI, VA and the countries of DE, IT, AT.

Nationwide Alabama Arizona California District of Columbia Florida Georgia Illinois New Hampshire New Jersey New York Oklahoma Oregon Pennsylvania Texas Virginia Washington Wisconsin

Questions about this recall

Is Trevo Trak 21 Microcatheter recalled?

Yes. Stryker Neurovascular recalled Trevo Trak 21 Microcatheter on 3 Jun 2022. The recall is Class II and its status is Ongoing. Recall number Z-1386-2022.

Why was it recalled?

Microcatheter product label on the carton is missing the microcatheter product drawing/illustration.

Which lots are affected?

REF/UDI/Lot: 90338/(01)07613327313956(17)231022(10)0000086176/0000086176; OUS: REF/Lot: 91412/46383767; 91413/46402565, 46383768, 46383779, 46383776; 91414/46383765, 46383772, 46383773, 46386864, 46383775, 46383774; 91415/46402572, 46383781, 46383771, 46383766; SFP914170/46383769; SFP914190/46383770

Where was it sold?

Worldwide distribution - US Nationwide distribution in the states of CA, OR, PA, NY, DC, IL, WA, NH, NJ, OK, FL, AZ, AL, GA, TX, WI, VA and the countries of DE, IT, AT.

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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