Boston Scientific recalls pancreatic stents made between Sept 2017 and Sept 2019 that were labeled with a 36-month shelf life instead of the approved 18-month shelf life. This may lead to improper use if the device expires before the procedure.
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 produced between September 2017 and September 2019 that were incorrectly labeled with a 36-month shelf life instead of the required 18-month shelf life. This could lead to improper use if the device expires before the procedure.
The stents were labeled with a 36-month shelf life instead of the approved 18-month shelf life. This could lead to improper use if the device expires before the procedure, potentially causing complications.
Patients who received the recalled stents during procedures between September 2017 and September 2019. Medical professionals using these stents for pancreatic procedures are most at risk.
Check the lot numbers on the stent: 21376782, 21636753, 21724127, 21833853, 22007181, 22136472, 22195529, 22212529, 22522255, 22613956, 22858807, 23073638, 23321211, 23408729, 23875252, 24167479, 24229866, 24411528. The product was sold between September 2017 and September 2019.
Look for the lot numbers listed: 21376782, 21636753, 21724127, 21833853, 22007181, 22136472, 22195529, 22212529, 22522255, 22613956, 22858807, 23073638, 23321211, 23408729, 23875252, 24167479, 24229866, 24411528.
The stents were 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 procedure.
Check the lot number on the stent. If it matches the listed numbers, contact Boston Scientific for further instructions.
The stents were manufactured 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-0554-2020 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0554-2020 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.
