Boston Scientific recalls EndoVive Replacement Button Kits with incorrect size labels that may cause button embedding and serious complications. Affected kits have UPN M00509500 or M00509510.
Affected batches of the kit contain Stoma Measuring Devices sized to measure for an 18/24F replacement button, but are labeled as being for a 28F. Use of defective product may lead to undersizing the button, which may cause embedding with erosion into the gastric wall, tissue necrosis, infection, sepsis, and associate sequelae.
Boston Scientific is recalling EndoVive Replacement Button Kits that were labeled for a 28F size but actually measure for an 18/24F size. Using these kits could cause the button to be too small, leading to tissue damage, infection, or severe complications.
The kit is labeled for a 28F button size but actually measures for an 18/24F size. This mismatch can cause the button to be too small, embedding into the stomach wall and potentially causing tissue damage, infection, or severe complications.
Patients using EndoVive button systems who have the specific kit models with UPN M00509500 or M00509510 are affected. Those with gastric buttons that require precise sizing are at highest risk.
Check the outer box for UPN M00509500 or M00509510. The kit may also have GTIN numbers 08714729902713 or 08714729902720.
Look for UPN M00509500 or M00509510 on the outer box to identify affected kits.
This kit measures for an 18/24F button size but is labeled as 28F.
Using this kit may cause the button to be too small, leading to embedding in the stomach wall, tissue damage, infection, or severe complications.
Check the outer box for UPN M00509500 or M00509510. The kit may also have GTIN numbers 08714729902713 or 08714729902720.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1153-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1153-2024 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.
