Boston Scientific recalls EndoVive 20Fr Push Safety PEG Kits with ENFit for stomach feeding due to risk of blocked tube during placement, potentially causing bleeding or aspiration. Affected units have specific lot numbers.
Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events which may include additional intervention to close the puncture site, bleeding, leakage of gastric contents, and aspiration
Boston Scientific is recalling EndoVive 20Fr Push Safety PEG Kits with ENFit for stomach feeding because the barb connector can block the feeding tube during placement. This may cause prolonged procedures, bleeding, leakage, or aspiration if not fixed.
The barb connector in the kit can block the feeding tube during placement, causing the procedure to take longer. This may lead to complications like bleeding, leakage of stomach contents, or aspiration if the tube isn't properly placed.
Patients who use this feeding tube kit for stomach nutrition, especially those who are unable to eat normally. Those with medical conditions requiring frequent tube adjustments are at higher risk.
Check for the EndoVive 20Fr Push Safety PEG Kit with ENFit (Box 2) labeled for stomach feeding. Affected units have specific lot numbers listed in the recall notice.
Look for the lot numbers listed in the recall: 32257549, 32257552, 32267521, 32270820, 32358475, 32358478, 32367048, 32374780, 32374781, 32385061, 32506053, 32506054, 32515036, 32531791, 32545183, 32545184, 32623024, 32802227, 32802228, 32810934, 32810935, 32958981, 32958982, 32968819, 32970723, 33080372, 33080373, 33087966, 33209008
The barb connector can block the feeding tube during placement, which may cause prolonged procedures, bleeding, leakage of stomach contents, or aspiration.
Check the lot numbers listed in the recall notice to see if your kit is affected. If it is, contact Boston Scientific for instructions.
The recall notice does not specify a fix or remedy for this issue.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1513-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1513-2024 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.
