Boston Scientific recalls EndoVive 20Fr Push Safety PEG Kits for potential feeding tube blockage during placement, risking prolonged procedures and complications like 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 that may block the feeding tube during placement, causing longer procedures and risks like bleeding or aspiration. This affects patients needing enteral nutrition who cannot eat normally.
The barb connector in the kit can block the feeding tube during placement, making it difficult to advance the guidewire. This may prolong the procedure, leading to complications such as bleeding, leakage of stomach contents, or aspiration.
Patients who need enteral nutrition through a feeding tube and are unable to consume food normally. Those with the specific lot numbers listed in the recall are most at risk.
Check the lot numbers on the product box: 32295181, 32295182, 32306054, 32306055, 32316800, 32323673, 32342013, 32367049, 32367050, 32374782, 32472868, 32486230, 32486231, 32486232, 32486233, 32506056, 32515039, 32523243, 32523244, 32531793, 32531794, 32531795, 33113026, 33113027, 33113028, 33113029, 33170338. The kit is intended for enteral nutrition in patients who cannot eat normally.
Look for the specific lot numbers listed in the recall on the product box.
The barb connector may block the feeding tube during placement, causing prolonged procedures and risks like bleeding or aspiration.
Patients who need enteral nutrition through a feeding tube and are unable to consume food normally, especially those with the listed lot numbers.
Check the lot numbers on the product box. If you have the listed lot 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-1515-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1515-2024 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.
