Boston Scientific recalls certain Advanix Pancreatic Stents due to incorrect shelf life labeling (36 months instead of 18 months). Affected units include specific lot numbers and model UPN M00536620.
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 approved 18-month shelf life. This could lead to potential issues with the stent's safety and effectiveness if used beyond the intended time frame.
The stent was incorrectly labeled with a 36-month shelf life instead of the approved 18-month shelf life. This could mean the stent might not be safe or effective after the intended time period, potentially leading to complications if used beyond its safe expiration.
Patients who received the recalled stents during the specified manufacturing period (Sept 2017 - Sept 2019) are most at risk. Healthcare providers who use these stents for medical procedures may also be affected.
Check for the model UPN M00536620 and lot numbers 21776487, 22136470, 22896244, or 23902871. The stents were manufactured between September 29, 2017, and September 12, 2019.
Verify the model UPN M00536620 and lot numbers listed in the recall notice.
The stent was labeled with a 36-month shelf life instead of the approved 18-month shelf life, which could affect its safety and effectiveness.
Lot numbers 21776487, 22136470, 22896244, and 23902871 are affected.
The stents were manufactured between September 29, 2017, and September 12, 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-0549-2020 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0549-2020 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.
