Vascutek recalls Gelsoft Plus and Gelweave vascular repair devices that were incorrectly labeled with an additional month of shelf life. The device expiry should have been calculated from gel impregnation (date of manufacture) but was incorrectly calculated from device packaging.
Gelatin sealed woven polyester prostheses devices, designed for vascular repair, were incorrectly labeled with an additional month of shelf life. Device expiry should have been calculated from gel impregnation (date of manufacture) but it was incorrectly calculated from device packaging.
Vascutek is recalling Gelsoft Plus and Gelweave vascular repair devices that were incorrectly labeled with an additional month of shelf life. The device expiry should have been calculated from the date of manufacture (gel impregnation) but was incorrectly calculated from the device packaging. This could lead to devices being used past their expiration date.
The devices were incorrectly labeled with an additional month of shelf life. The expiration date should have been calculated from the date of manufacture (gel impregnation) but was instead calculated from the device packaging. This could lead to devices being used past their expiration date.
Patients who own or use these vascular repair devices are affected. The risk is low as the issue is a labeling error, not a safety hazard.
Check for Gelsoft Plus devices with item numbers ending in 'PE' or 'PE-B' (e.g., 635024PE, 635024PE-B) or Gelweave devices with item numbers ending in 'E' or 'E-B' (e.g., 736038E, 736038E-B).
Look for item numbers ending in 'PE' or 'PE-B' for Gelsoft Plus devices, or ending in 'E' or 'E-B' for Gelweave devices.
The device expiry should have been calculated from the date of manufacture (gel impregnation) but was incorrectly calculated from the device packaging.
Check for Gelsoft Plus devices with item numbers ending in 'PE' or 'PE-B' (e.g., 635024PE, 635024PE-B) or Gelweave devices with item numbers ending in 'E' or 'E-B' (e.g., 736038E, 736038E-B).
Check the device label for the item number. If it matches the recalled items, contact Vascutek for further instructions.
We’ve drafted a message you can send Vascutek to request your refund or repair — edit it as you like.
Subject: Recall Z-1492-2026 — Vascutek Vascutek Hello, I own a Vascutek that is covered by recall Z-1492-2026 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.
