Boston Scientific recalls pancreatic stents with incorrect 36-month shelf life labeling instead of approved 18-month. Affected units may expire before use.
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 pancreatic stents that were labeled with a 36-month shelf life instead of the required 18-month shelf life. This could mean the stents expire before they're used, potentially causing complications during medical procedures.
The stent was labeled with a longer shelf life than approved, which could lead to expiration before medical use. This might cause the stent to become ineffective or unsafe during procedures.
Patients who have been prescribed this specific pancreatic stent by their doctor. Those with the lot numbers 21542436, 21897084, or 23230412 are most at risk.
Check for the lot numbers 21542436, 21897084, or 23230412 on the stent packaging. The product is a Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 18cm with UPN M00536730.
Verify the product's shelf life label matches the approved 18-month period for medical use.
The stent was labeled with a 36-month shelf life instead of the approved 18-month shelf life, which could lead to expiration before medical use.
Lot numbers 21542436, 21897084, and 23230412.
The stent may expire before use, potentially causing complications during medical procedures if used after expiration.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0560-2020 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0560-2020 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.
