Boston Scientific recalls Advanix Pancreatic Stent models with incorrect 36-month shelf life label instead of approved 18-month. Affected units sold between Sep 2017 and Sep 2019. No immediate action needed but check for specific lot numbers.
Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
Boston Scientific is recalling certain pancreatic stents that were labeled with a 36-month shelf life instead of the required 18-month shelf life. This labeling error could lead to improper use if the device expires before the intended medical procedure.
The stent was labeled with a 36-month shelf life instead of the approved 18-month shelf life. This could mean the device expires earlier than intended, potentially causing complications during medical procedures if used after the expiration date.
Patients who received the recalled stents between September 2017 and September 2019. Medical professionals using these specific models during procedures are most at risk.
Check for lot numbers: 21483842, 21512596, 21724129, 21806787, 21973221, 22307744, 22460195, 23073639, 23492663, or 24271829. These stents were sold between September 2017 and September 2019.
Look for the lot numbers listed: 21483842, 21512596, 21724129, 21806787, 21973221, 22307744, 22460195, 23073639, 23492663, or 24271829.
The stent was labeled with a 36-month shelf life instead of the approved 18-month shelf life, which could lead to improper use if the device expires before the intended medical procedure.
Check the lot number against the list provided. If it matches, contact Boston Scientific for further instructions.
The recall is for labeling error, not a safety hazard. No immediate action is needed but verification of the lot number is recommended.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0557-2020 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0557-2020 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.
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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.
