Boston Scientific recalls Advanix Pancreatic Stents with incorrect 36-month shelf life label instead of approved 18-month. Affected units may need re-evaluation by healthcare providers.
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 Advanix Pancreatic Stents that were labeled with a 36-month shelf life instead of the approved 18-month shelf life. This labeling error could lead to improper use if the stent is used beyond its intended shelf life.
The stent was labeled with a 36-month shelf life instead of the approved 18-month shelf life. This could mean the stent might be used after its expiration date, potentially leading to complications if the stent degrades over time.
Healthcare providers who use or store these stents may be affected. Patients using these stents are at low risk as the stent itself is not the hazard.
Check for lot codes: 21973220, 22522254, or 23837823. The stent model is Advanix Pancreatic Stent, Straight Leading Barb, 10F x 6cm UPN.
Identify the lot code on the stent packaging to determine if it's affected (21973220, 22522254, or 23837823).
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 stent is used beyond its intended shelf life.
Check the lot code on the stent packaging. If it matches the affected lot codes (21973220, 22522254, or 23837823), contact Boston Scientific for guidance.
This recall is low risk as the stent itself is not the hazard; the issue is a labeling error that could lead to improper use if the stent is used beyond its intended shelf life.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0551-2020 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0551-2020 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.
