Boston Scientific recalls Advanix Pancreatic Stent models with incorrect 36-month shelf life label instead of approved 18-month. Affected units sold between Sept 2017-2019.
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 when it should have been 18 months. This error means the device might expire before the intended medical procedure, potentially causing complications if used after expiration.
Patients who received this specific pancreatic stent model between September 2017 and September 2019. Medical professionals using these stents for procedures are most at risk of using expired devices.
Check for lot numbers: 21615214, 21678783, 22036151, 22423474, 23230411, 23321212, or 24167940. The product was sold between September 2017 and September 2019.
Look for lot numbers listed: 21615214, 21678783, 22036151, 22423474, 23230411, 23321212, or 24167940.
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 procedure.
Check the lot number on your device. If it matches the listed numbers, contact Boston Scientific for further instructions.
The product was sold between September 2017 and September 2019.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0559-2020 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0559-2020 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.
