Boston Scientific Corporation: EndoVive 20Fr Push Safety PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consum

Hazard

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

Details from the source

Reason for recall: 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 Distribution: Worldwide distribution - US Nationwide and the country of Japan. Quantity: 2726 units Lot/code info: GTIN: 08714729880417 Lot Numbers: 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

UPC codes

08714729880417

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.