EndoVive Gastrostomy Tube, Straight, with ENFit Connector M00509920Recalls & reported problems
Xeridiem Medical Devices, Inc. · EndoVive Gastrostomy Tube, Straight, with ENFit Connector, 20FR · 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 00813939023626), received between Feb 18, 2019 and Feb 18, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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 Appears to Trigger Rejection1
Patient problems
- Edema1
- Fluid Discharge1
- Skin Inflammation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 18, 2019Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
THE CATHETER HAS CAUSED A CLEAR CUTANEOUS REACTION, WITH EDEMA AND INFLAMMATION OF THE SKIN AND LEAKAGE OF LIQUID. AFTER TWO MONTHS IT WAS NECESSARY TO REPLACE THE ENDOVIVE CATHETER. DURING REMOVAL, NURSE FOUND A LOT OF RESISTANCE FROM THE ANCHORING BALLOON THAT WAS COMPLETELY FILLED WITH ENCRUSTATIONS MATERIAL OF UNCLEAR ORIGIN. THE BALLOON WAS PARTIALLY FOLDED IN ON ITSELF AND THEN ANCHORED INSIDE THE FISTULOUS TRACT. INCIDENT CONSEQUENCE: MEDICAL INTERVENTION - NECESSITY OF EARLY CHANGE OF THE CATHETER, SERIOUS CUTANEOUS REACTION, PAIN IN REMOVAL PHASE.
Patient problems: Edema; Fluid Discharge; Skin Inflammation
MAUDE report 8348288 ↗
Other Gastrointestinal Tubes With Enteral Specific Connectors devices
- EndoVive Safety PEG Kit M00509000Boston Scientific Corporation · Gastrointestinal Tubes with Enteral Specific Connectors1 recall32 reports
- EndoVive Safety PEG Kit M00509010Boston Scientific Corporation · Gastrointestinal Tubes with Enteral Specific Connectors1 recall16 reports
- EndoVive Standard PEG Kit M00509050Boston Scientific Corporation · Gastrointestinal Tubes with Enteral Specific Connectors1 recall6 reports
- Salem Sump 8888264986ECardinal Health 200, LLC · Gastrointestinal Tubes with Enteral Specific Connectors1 recall1 death2 reports
- Salem Sump 8888268060ECardinal Health 200, LLC · Gastrointestinal Tubes with Enteral Specific Connectors1 recall0 reports
- Salem Sump 7771810ECardinal Health, Inc. · Gastrointestinal Tubes with Enteral Specific Connectors28 reports
- Salem Sump 7771610ECardinal Health, Inc. · Gastrointestinal Tubes with Enteral Specific Connectors1 death18 reports
- Edi Catheter ENFit 6Fr/49 cm, 5pcs 6883898Maquet Critical Care AB · Gastrointestinal Tubes With Enteral Specific Connectors14 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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