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.
The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.
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.
The Instructions for Use (IFU) were distributed to international consignees instead of U.S. consignees. This is a labeling error that does not affect the safety or function of the vascular grafts themselves.
U.S. medical professionals who may have received these vascular grafts. The risk is minimal as this is a distribution error, not a safety hazard.
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.
Review the product names and model numbers listed in the recall notice to confirm if your vascular grafts are affected.
No action is required. This is a distribution error in the Instructions for Use, not a safety issue.
Vascutek recalls Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem, GelsoftPlus ERS Ax-Fem, Gelweave Straight, Gelweave Trifurcate, Gelweave Ant-Flo, and Gelweave Valsalva vascular grafts with model numbers REF 631408 to 632211.
No. This is a distribution error in the Instructions for Use, not a safety issue.
We’ve drafted a message you can send Vascutek to request your refund or repair — edit it as you like.
Subject: Recall Z-2542-2021 — Vascutek Vascutek Hello, I own a Vascutek that is covered by recall Z-2542-2021 from Vascutek. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
