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Unrated Medical device recall · FDA · Published April 29, 2022

Maquet Intergard Woven Vascular Graft Mislabeled - Product Size Error

Maquet recalls Intergard Woven Vascular Grafts labeled as 8mm x 30cm but actually 32mm x 30cm. This mislabeling could lead to improper use in medical procedures.

🇺🇸 FDA recall #Z-1282-2022Medical deviceMaquet ›
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Recalling firmMaquet Cardiovascular, LLC45 Barbour Pond Dr · Wayne, NJ 07470-2094
✎ GovInfoNow plain-language explainer

Maquet is recalling Intergard Woven Vascular Grafts that were mislabeled. The product was advertised as 8mm diameter and 30cm length but actually contains a 32mm diameter graft. This size difference could cause improper use during medical procedures. Read more at govinfonow.com/recall/60746-maquet-intergard-woven-vascular-graft-mislabeled-product-size-error.

Source Summary by GovInfoNow · govinfonow.com/recall/60746-maquet-intergard-woven-vascular-graft-mislabeled-product-size-error · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1282-2022

Cite this page

“Maquet Intergard Woven Vascular Graft Mislabeled - Product Size Error.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60746-maquet-intergard-woven-vascular-graft-mislabeled-product-size-error. Based on FDA recall #Z-1282-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1282-2022%22&limit=1).

Maquet Cardiovascular, LLC voluntarily recalled one INTERGARD Woven Vascular Graft due to mislabeling hazards, according to the FDA on April 29, 2022. The product labeled as a specific size contained a different dimension.

How to tell if you have it

  • Brand: Maquet
  • Product: INTERGARD Woven Vascular Graft
  • UPC: 00384401000280

The hazard

The product labeled as Intergard Woven Straight graft REF IGW0032-30, D: 8 mm, L: 30 cm contained an Intergard Woven Straight graft of D: 32 mm and L: 30 cm. The FDA classified this mislabeling issue as a Class II recall.

Context

GovInfoNow's records show Maquet Cardiovascular, LLC has 25 other recalls on record since Jan. 24, 2019. Other recent recalls of similar products include Micro Therapeutics Pipeline Flex Embolization Device Labeling Error (June 8, 2026), Micro Therapeutics Pipeline Flex Embolization Device Recall: Incorrect Diameter Label (June 25, 2026), and Micro Therapeutics Pipeline Flex Embolization Device: Incorrect Labeling Risk (June 8, 2026).

How to tell if you have this one

Check for the product label stating 'Intergard Woven Straight graft REF IGW0032-30, D: 8 mm, L: 30 cm'. The actual grafts contain a 32mm diameter instead of 8mm.

  • Brand
    Maquet
  • Product
    INTERGARD Woven Vascular Graft is a woven polyester graft coated with a bovine collagen. It has an external velour
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Label

    Look for the label that states 'Intergard Woven Straight graft REF IGW0032-30, D: 8 mm, L: 30 cm' on the product.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide distribution in the state of SC.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 2 years after the firm started it.

1. Firm started the recall: Apr 29, 202212. FDA classified it Class II: Jun 23, 202223. Published in FDA’s Enforcement Report: Jun 29, 202234. FDA terminated the recall: Apr 18, 2024420222024
  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-1282-2022 (April 29, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1282-2022 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