W L Gore recalls specific heparin stents due to incorrect labeling that may contain a larger size than listed. Affected units have serial numbers starting with 22753580.
Incorrect labeling, specifically, expandable endoprosthesis labeled as 8 mm x 59mm x 135 cm, however may contain a 9mm x 29 mm x 135 cm device.
W L Gore is recalling a specific type of heparin stent that may have incorrect labeling. This could mean the stent is larger than listed, which might cause complications during medical procedures.
The stent is labeled as 8 mm x 59 mm but may actually be 9 mm x 29 mm. This size difference could lead to improper placement during medical procedures, potentially causing complications.
Medical professionals using the specific stent model are likely affected. Patients receiving this stent during procedures may be at risk if the size is incorrect.
Check for serial numbers starting with 22753580 on the stent packaging. The product is labeled as Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON.
Look for the serial number starting with 22753580 on the stent packaging.
The stent may be incorrectly labeled as 8 mm x 59 mm but could actually be 9 mm x 29 mm, which might cause complications during medical procedures.
Check the serial number on the packaging. If it starts with 22753580, contact W L Gore for further instructions.
The recall is for potential size mismatch, which could lead to complications but does not indicate a risk of serious injury in normal use.
We’ve drafted a message you can send W L Gore to request your refund or repair — edit it as you like.
Subject: Recall Z-0077-2022 — W L Gore W L Gore Hello, I own a W L Gore that is covered by recall Z-0077-2022 from W L Gore. 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.
