Gore recalls biliary endoprosthesis stents and drains that may be shorter than labeled, potentially causing improper placement in bile ducts. Affected units include specific catalog and serial numbers.
The Gore post market surveillance team received a complaint that a GORE¿ VIABIL¿ Biliary Endoprosthesis appeared shorter than the labeled length.
Gore is recalling biliary stents, drains, and dilators that may be shorter than labeled. This could lead to improper placement in bile ducts during medical procedures, risking complications.
The recalled devices may be shorter than labeled, which could cause improper placement in the bile ducts during medical procedures. This might lead to complications such as blockages or infections if the device doesn't function as intended.
Patients using the recalled biliary endoprosthesis for bile duct procedures are most at risk. Healthcare providers who have these devices in their inventory may also be affected.
Check for catalog numbers VH1008040, VH1010040, VN1010040, VN0808200. Look for serial numbers starting with 22552467 through 22552782 and 22613929 through 22613931.
Verify the catalog number and serial number against the list provided in the recall notice.
The Gore post market surveillance team received a complaint that the biliary endoprosthesis appeared shorter than the labeled length.
Catalog numbers: VH1008040, VH1010040, VN1010040, VN0808200. Serial numbers: 22552467 through 22552782 and 22613929 through 22613931.
No, the recall does not require immediate discontinuation. Patients should check the device details and contact their healthcare provider if they have the affected units.
We’ve drafted a message you can send Gore to request your refund or repair — edit it as you like.
Subject: Recall Z-1593-2021 — Gore Gore Hello, I own a Gore that is covered by recall Z-1593-2021 from 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.
