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Lower risk Medical device recall · FDA · Published November 28, 2017

Stryker Neurovascular Trevo XP ProVue System Kit Recall: Carton Sleeve Mismatch

Stryker Neurovascular recalls Trevo XP ProVue System kits with mismatched carton sleeve and contents. Affected kits may have incorrect packaging. No immediate action needed as the hazard is cosmetic.

🇺🇸 FDA recall #Z-0347-2018Medical deviceStryker Neurovascular ›
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Recalling firmStryker Neurovascular47900 Bayside Pkwy · Fremont, CA 94538-6515
✎ GovInfoNow plain-language explainer

What happened, in plain English

Stryker Neurovascular is recalling a specific medical kit that may have a mismatch between the carton sleeve and the actual contents. This issue does not pose a safety risk but could cause confusion during use. Read more at govinfonow.com/recall/72470-stryker-neurovascular-trevo-xp-provue-system-kit-recall-carton-sleeve.

Source Summary by GovInfoNow · govinfonow.com/recall/72470-stryker-neurovascular-trevo-xp-provue-system-kit-recall-carton-sleeve · Updated August 31, 2026 · FDA enforcement record: FDA #Z-0347-2018

Cite this page

“Stryker Neurovascular Trevo XP ProVue System Kit Recall: Carton Sleeve Mismatch.” GovInfoNow, updated August 31, 2026. https://govinfonow.com/recall/72470-stryker-neurovascular-trevo-xp-provue-system-kit-recall-carton-sleeve. Based on FDA recall #Z-0347-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0347-2018%22&limit=1).

Why it’s dangerous

The carton sleeve does not match the physical contents of the pack. This mismatch could lead to confusion about what items are included, but it does not cause injury or malfunction during normal use.

Who’s affected

Healthcare professionals using the Trevo XP ProVue System kit for medical procedures are most likely affected. The recall applies to kits sold with specific model numbers.

How to tell if you have this one

Check for the model number 80052 and lot number 63034 on the carton. The kit includes a Trevo XP ProVue Retriever and 4x20mm components.

  • Brand
    Stryker Neurovascular
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Verify Kit Contents

    Compare the carton sleeve with the actual items in the kit to ensure they match the model number 80052.

How this recall unfolded

Recall timeline

FDA terminated this recall 2.4 years after the firm started it.

1. Firm started the recall: Nov 28, 201712. FDA classified it Class II: Jan 14, 201823. Published in FDA’s Enforcement Report: Jan 24, 201834. FDA terminated the recall: Apr 28, 2020420172020
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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

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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-0347-2018 (November 28, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0347-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on August 31, 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