Boston Scientific recalls certain Advanix Pancreatic Stents due to incorrect shelf life labeling (36 months vs approved 18 months). Affected units sold between Sept 2017-2019 may need attention.
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 specific pancreatic stents that were labeled with a 36-month shelf life instead of the required 18 months. This mismatch could lead to product failure if used beyond the safe expiration period.
The stents were labeled with a 36-month shelf life when they should have been labeled with 18 months. Using them beyond this period could cause failure, but this is a labeling error rather than a safety hazard in normal use.
Patients who received the recalled stents between September 2017 and September 2019. Medical professionals using these stents for pancreatic procedures are most at risk.
Check for lot numbers: 21285272, 21568464, 21750673, 21865109, 22072355, 22613957, 23408730, or 23492662. The product was sold between September 2017 and September 2019.
Look for the lot numbers listed: 21285272, 21568464, 21750673, 21865109, 22072355, 22613957, 23408730, or 23492662.
The stents were labeled with a 36-month shelf life instead of the approved 18-month shelf life, which could lead to failure if used beyond the safe expiration period.
Check for the lot numbers: 21285272, 21568464, 21750673, 21865109, 22072355, 22613957, 23408730, or 23492662. The product was sold between September 2017 and September 2019.
The recall is for labeling correction, not immediate action. Check the lot number to see if your stent is affected.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0555-2020 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0555-2020 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.
