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Lower risk Medical device recall · FDA · Published July 8, 2021

Vascutek Gelsoft Vascular Grafts: IFU Distribution Error Recall

Vascutek recalls certain Gelsoft vascular grafts due to incorrect Instructions for Use distribution to international consignees instead of U.S. consignees. No action required for users.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2542-2021Medical deviceVascutek ›
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Contact the company

Recalling firmVascutek, Ltd.Newmains Avenue · Inchinnan, United Kingdom
✎ GovInfoNow plain-language explainer

Vascutek is recalling specific Gelsoft Plus and Gelweave vascular grafts because the Instructions for Use were distributed to international consignees instead of U.S. consignees. This is a distribution error, not a safety issue, so users do not need to take any action. Read more at govinfonow.com/recall/62232-vascutek-gelsoft-vascular-grafts-ifu-distribution-error-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/62232-vascutek-gelsoft-vascular-grafts-ifu-distribution-error-recall · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2542-2021

Cite this page

“Vascutek Gelsoft Vascular Grafts: IFU Distribution Error Recall.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62232-vascutek-gelsoft-vascular-grafts-ifu-distribution-error-recall. Based on FDA recall #Z-2542-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2542-2021%22&limit=1).

The FDA announced on July 8, 2021, that Vascutek, Ltd. recalled The Instructions for Use (IFU) for Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem, GelsoftPlus ERS Ax-Fem, and Gelweave vascular grafts because the devices contained IFUs intended for rest of world consignees rather than U.S. consignees.

How to tell if you have it

  • Vascutek Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis, Bifurcate, REF 631408
  • Vascutek Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis, Bifurcate, REF 631608
  • Vascutek Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis, Bifurcate, REF 631809
  • Vascutek Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis, Bifurcate, REF 632010
  • Vascutex Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis, Bifurcate, REF 632211

The hazard

The recalled vascular grafts contained the Instructions for Use (IFU) for distribution to rest of world consignees rather than U.S. consignees.

Context

GovInfoNow's records show Vascutek, Ltd. has one other recall on record since 2025-12-18 involving incorrect shelf life labeling for Gelsoft Plus and Gelweave devices. Other recent recalls of similar products include Boston Scientific FARASTAR Ablation Generator EU Recall (2026-06-11), Intervascular Cardioroot Vascular Grafts May Fail Water Permeability Test (2026-08-12), and LeMait: Artegraft Vascular Graft Recall Due to Labeling Mix-Up (2026-02-10).

How to tell if you have this one

Check for the product names: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem, GelsoftPlus ERS Ax-Fem, Gelweave Straight, Gelweave Trifurcate, Gelweave Ant-Flo, or Gelweave Valsalva. Look for specific model numbers like REF 631408 to 632211.

  • Brand
    Vascutek
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    Distribution was made to PR and Guam.
Recall numberProduct, codes & lots
Z-2542-2021The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem, GelsoftPlus ERS Ax-Fem, Gelweave Straight, Gelweave Trifurcate, Gelweave Ant-Flo, and Gelweave Valsalva vascular grafts: (1) Vascutek Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis, Bifurcate, 14 x 8mm, Bifurcate 45cm, REF 631408, sterile. (2) Vascutek Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis, Bifurcate, 16 x 8mm, Bifurcate 45cm, REF 631608, sterile. (3) Vascutek Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis, Bifurcate, 18 x 9mm, Bifurcate 45 cm, REF 631809, sterile. (4) Vascutek Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis, Bifurcate, 20 x 10mm, Bifurcate 45cm, REF 632010, sterile. (5) Vascutex Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis, Bifurcate, 22 x 11mm, Bifurcate 45cm, REF 632211, sterile; To be reported.
Z-2543-2021The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches. FSN says Tapered Carotid Patch 920875t; To be reported.
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Review the product names and model numbers listed in the recall notice to confirm if your vascular grafts are affected.

Where it went and when

Where it was distributed

Distributed in Puerto Rico.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFLPuerto Rico: yesPR

FDA distribution: “Distribution was made to PR and Guam.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Puerto Rico.

Recall timeline

FDA terminated this recall 3.1 years after the firm started it.

1. Firm started the recall: Jul 8, 202112. FDA classified it Class II: Sep 24, 202123. Published in FDA’s Enforcement Report: Oct 6, 202134. FDA terminated the recall: Aug 19, 2024420212024
  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-2542-2021 (July 8, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2542-2021 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