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Lower risk Medical device recall · FDA · Published June 3, 2022

Stryker Trevo Trak 21 Microcatheter: Missing Product Label Drawing

Stryker recalls specific Trevo Trak 21 Microcatheter models due to missing product drawing on carton labels. This may affect medical device safety during procedures.

🇺🇸 FDA recall #Z-1386-2022Medical deviceStryker ›
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Recalling firmStryker Neurovascular47900 Bayside Pkwy · Fremont, CA 94538-6515
✎ GovInfoNow plain-language explainer

Stryker is recalling certain Trevo Trak 21 Microcatheter models because the carton labels lack the required product drawing. This could lead to confusion during medical procedures if healthcare providers cannot identify the correct device. Read more at govinfonow.com/recall/60556-stryker-trevo-trak-21-microcatheter-missing-product-label-drawing.

Source Summary by GovInfoNow · govinfonow.com/recall/60556-stryker-trevo-trak-21-microcatheter-missing-product-label-drawing · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1386-2022

Cite this page

“Stryker Trevo Trak 21 Microcatheter: Missing Product Label Drawing.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60556-stryker-trevo-trak-21-microcatheter-missing-product-label-drawing. Based on FDA recall #Z-1386-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1386-2022%22&limit=1).

The FDA announced on June 3, 2022, that Stryker Neurovascular is voluntarily recalling Trevo Trak 21 Microcatheters because product labels are missing required illustrations, according to the FDA.

How to tell if you have it

  • 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

The hazard

The microcatheter product label on the carton is missing the microcatheter product drawing or illustration, according to the FDA.

Context

GovInfoNow's records show Stryker Neurovascular has 16 other recalls on record since June 26, 2017. Other recent recalls of similar products include Stryker INZONE Detachment System (April 6, 2026), Stryker Trevo Trak 21 Microcatheter Recall (April 23, 2024), and Stryker CS Uni-Directional w Auto ID Catheter Recall (April 10, 2026).

How to tell if you have this one

Check for the product codes: REF 90338, 91412, 91413, 91414, 91415, SFP914170, or SFP914190. These models were sold with specific lot numbers and reference codes.

  • Brand
    Stryker
  • Product
    Trevo Trak 21 Microcatheter, REF: 90338. TREVO NXT 3X32+TRAK21 2-PACK - CE, REF: 91412; TREVO NXT 4X28+TRAK21 2-PACK
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Label

    Look for the product drawing on the carton label to confirm the microcatheter model.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 16 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: nationwideMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: named in the noticeORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: nationwideMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: named in the noticeDCOklahoma: named in the noticeOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “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.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, California, District of Columbia, Florida, Georgia, Illinois, New Hampshire, New Jersey, New York, Oklahoma, Oregon, Pennsylvania, Texas, Virginia, Washington, Wisconsin.

Recall timeline

FDA published this recall 54 days after the firm started it.

1. Firm started the recall: Jun 3, 202212. FDA classified it Class II: Jul 15, 202223. Published in FDA’s Enforcement Report: Jul 27, 202232022
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

Do I need to stop using these products?

No action is required beyond checking the product label for the missing drawing. The recall does not require immediate discontinuation.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1386-2022 (June 3, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1386-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA