Reported Apr 17, 2024 · Ongoing
EndoVive 20Fr Push Standard PEG Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric…
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 100 Boston Scientific Way · Marlborough, MA · 01752-1234
Is this the product you have?
- EndoVive 20Fr Push Standard PEG Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means
- UPNM00568211
- Lot codes and dates
- GTIN08714729285205
- Lot Numbers
321518803224731132810232
- Amount recalled
- 1475 units
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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