Boston Scientific recalls EndoVive 20Fr Push Standard PEG Kits (Box 2) for pediatric and adult patients with blocked feeding tube lumen causing procedure delays and potential complications like bleeding or aspiration.
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 Standard PEG Kits (Box 2) for patients who need enteral nutrition. The kit may block the feeding tube during placement, causing procedure delays and potential complications like bleeding or aspiration.
The barb connector in the feeding tube may block during placement, causing the procedure to take longer. This can lead to additional interventions, bleeding, leakage of stomach contents, or aspiration.
Patients who require enteral nutrition through a feeding tube, especially pediatric and adult patients unable to eat normally. Those with the specific lot numbers mentioned in the recall are most at risk.
Check for the EndoVive 20Fr Push Standard PEG Kit (Box 2) with lot numbers 32151880, 32247311, or 32810232. The kit is intended for patients who cannot eat normally and requires enteral nutrition.
Look for lot numbers 32151880, 32247311, or 32810232 on the kit packaging.
Reach out to Boston Scientific for guidance on next steps if you have the recalled kit.
The barb connector may block during feeding tube placement, causing procedure delays and potential complications like bleeding or aspiration.
Patients who require enteral nutrition through a feeding tube, especially those with the specific lot numbers mentioned in the recall.
Check the lot number on the kit packaging. If it matches the recalled numbers, contact Boston Scientific for guidance.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1516-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1516-2024 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.