Boston Scientific recalls WallFlex Biliary RX Fully Covered Stent System RMV (10mmx60mm) due to mislabeling as covered when it's uncovered. This could lead to incorrect medical use.
Mislabeled: WallFlex Biliary RX Uncovered Stent System 10x60mm devices labeled as WallFlexTM Biliary RX Fully Covered Stent System RMV 10x60mm device
Boston Scientific is recalling a specific biliary stent system because it's mislabeled as a covered stent when it's actually an uncovered one. Using the wrong type could cause improper treatment or complications during medical procedures.
The stent is labeled as a fully covered type but is actually uncovered. This mislabeling could lead to incorrect medical procedures if the wrong stent is used during treatment for biliary obstructions.
Patients who received this specific stent system for biliary strictures or obstructions are likely affected. Medical professionals using the product for palliative treatment may also be at risk if they use the wrong stent type.
Check for the product name 'WallFlex Biliary RX Fully Covered Stent System RMV (10mmx60mm)' with lot code 25607019 and expiration date June 17, 2022. The product is used for palliative treatment of biliary strictures.
Look for the lot code 25607019 and expiration date June 17, 2022 on the stent packaging.
The stent is mislabeled as a fully covered stent when it's actually uncovered, which could lead to incorrect medical use.
The recall record does not specify a remedy, so check the product label for the lot code and expiration date to confirm if it's affected.
The recall indicates a mislabeling risk, but the product is not inherently unsafe. Correct use with proper labeling is required for safety.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2958-2020 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2958-2020 from Boston Scientific. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
