Boston Scientific recalls pancreatic stents with incorrect 36-month shelf life label instead of approved 18-month. Affected units sold between Sept 2017-2019. No action needed but check labels.
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 approved 18-month shelf life. This could lead to improper use if the stent expires before the intended medical procedure. The recall affects specific model numbers and production dates.
The stent was labeled with a 36-month shelf life instead of the approved 18-month shelf life. This could mean the stent becomes ineffective or unsafe if used after the intended expiration date for medical procedures.
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 the model number M005336690 on the stent packaging. Lot numbers 21568465, 21724128, 22072356, 22250324, 22480145, and 23902872 are affected. The stents were manufactured between September 2017 and September 2019.
Look for the model number M005336690 and affected lot numbers on the stent packaging.
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 expires before the intended medical procedure.
No action is required for the stent itself, but you should check the label to confirm it is not one of the affected models.
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-0556-2020 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0556-2020 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.