EndoVive 20 French G-Tube w/Right Angle Bolster [M00582150] [8215]Recalls & reported problems
Xeridiem Medical Devices, Inc. · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813939020045), received between Sep 19, 2016 and Sep 19, 2016 — classified as 1 injury.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Device Operates Differently Than Expected1
Patient problems
- Feeding Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 19, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
THE DEVICE WAS A REPLACEMENT AND THEY INFLATED THE BALLOON DURING THE PROCEDURE. THEY NOTICED THE NEXT DAY THAT THE PATIENT WAS LETHARGIC OR UNRESPONSIVE. THEY HAD SOME CONCERNS ABOUT THE TUBE BEING DISLODGED. THE PHYSICIAN CAME IN, DEFLATED THE TUBE, REINSERTED IT, REINFLATED IT, AND THEY MOVED THE PATIENT TO THE ICU. THEY STOPPED THE TUBE FEEDING AND HAD A CAT SCAN DONE LATER THAT DAY. IT WAS AFTER THAT POINT THAT THEY NOTICED SOME AIR OR FLUID, SO THEY REMOVED IT AND PUT AIR BACK IN TO REINFLATE THE BALLOON AND PUT IT ON THE TABLE TO WATCH IT AND THE BALLOON DEFLATED. THE BALLOON DEFLATED AND GOT DISLODGE. THE PATIENT WAS TRANSFERRED TO REHAB WITHIN THE HOSPITAL. HOSPITAL TOLD PATIENT'S HUSBAND THAT THE PRODUCT WAS DEFECTIVE, LEAKED AND CAUSED THE PATIENT SERIOUS INJURY. PATIENT IS ON A VENTILATOR, UNRESPONSIVE AND IS NOT IMPROVING.
Patient problems: Feeding Problem
MAUDE report 5961638 ↗
Other Tubes, Gastrointestinal (And Accessories) devices
- Bard® DigniShield® Stool Management System SMS002C. R. Bard, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)2 deaths525 reports
- CORTRAK* 2 ENTERAL ACCESS SYSTEM 20-0950Avanos Medical, Inc. · Tubes, gastrointestinal (and accessories)1 recall22 deaths134 reports
- Bard Tri-Funnel Replacement Gastrostomy Tube 000720Bard Access Systems, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 death170 reports
- EndoVive Safety PEG Kit M00566470Boston Scientific Corporation · TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 recall1 death111 reports
- Kangaroo 8884711253Cardinal Health, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)152 reports
- NutraGlide Nasal Feeding Tube ENFT-06090-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
- NutraGlide Nasal Feeding Tube ENFT-05090-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
- Kangaroo 8884711253ECardinal Health, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)100 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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