Vascutek recalls instructions for use for carotid and gelsoft vascular patches due to incorrect distribution to U.S. customers. No action needed as the issue is with shipping labels, not the product itself.
The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.
Vascutek recalled the instructions for use (IFU) for carotid and gelsoft vascular patches because they were shipped to U.S. customers instead of the rest of the world. This means the product itself is safe, but the shipping labels need correction to avoid confusion.
The instructions for use were intended for international shipments but were sent to U.S. customers. This could cause confusion about how to use the patches, but the patches themselves are safe and not defective.
U.S. customers who received the vascular patches with the incorrect instructions for use. Those most at risk are people who might have been confused by the shipping labels.
Check if you received the vascular patches with the label 'Tapered Carotid Patch 920875t' in the instructions for use. The recall is for shipments that were incorrectly labeled for U.S. customers.
Review the instructions for use (IFU) that came with your vascular patches to see if they include the label 'Tapered Carotid Patch 920875t'.
No, the patches themselves are safe. The recall is about the instructions for use being sent to the wrong region.
You do not need to take action. The issue is with the shipping labels, not the product itself.
No, the patches are safe. The recall is for incorrect distribution of instructions, not a defect in the product.
We’ve drafted a message you can send Vascutek to request your refund or repair — edit it as you like.
Subject: Recall Z-2543-2021 — Vascutek Vascutek Hello, I own a Vascutek that is covered by recall Z-2543-2021 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.
