EndoVive Gastrostomy Tube, Right Angle, with ENFit Connector M00510010Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00813939023770), received between Nov 25, 2025 and Nov 25, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (6 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 25, 2025Leak/Splash; Leak/Splash

  ECN EVENT DESCRIPTION: SITUACI6N QUE NOS REPORTAN EN SURA DE LAS SONDAS DE RECAMBIO ENFIT, HAN TENIDO MAS DE 5 PCTES, LAS CUALES HAN PRESENTADO SANGRADO PERIOSTOMAL DESDE EL CAMBIO DE LAS SONDAS, FILTRACIONES, DAI'IO DEL ESTOMA Y PIEL PERILESIONAL, ESTO NO HABIA OCURRIDO ANTES Y SE HA VENIDO EVIDENCIANDO DESDE LAS COLOCACIONES DE SEPTIEMBRE, AGRADEZCO CON LATAM SI PUEDES VALIDAR SI HAN PRESENTADO UNA SITUACI6N SIMILAR. COMPARTO EVIDENCIAS FOTOGRAFICAS DE LAS CASES SITUATION REPORTED TO US AT SURA REGARDING ENFIT REPLACEMENT TUBES: THEY HAVE HAD MORE THAN 5 PATIENTS WHO HAVE PRESENTED PERISTOMAL BLEEDING SINCE THE TUBE CHANGE, LEAKS, DAMAGE TO THE STOMA AND PERILESIONAL SKIN. THIS HAD NOT OCCURRED BEFORE AND HAS BEEN EVIDENT SINCE THE SEPTEMBER PLACEMENTS. I WOULD APPRECIATE IT IF LATAM COULD VALIDATE WHETHER THEY HAVE PRESENTED A SIMILAR SITUATION. I SHARE PHOTOGRAPHIC EVIDENCE OF THE CASES WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: VALORACI6N PAR ESPECIALISTA - SPECIALIST ASSESSMENT WHAT IS THE NEXT COURSE OF ACTION?: VALORACI6N PAR ESPECIALISTA - SPECIALIST ASSESSMENT PATIENT PRESENT AT TIME OF EVENT?: YES PATIENT COMPLICATIONS

  Patient problems: Abdominal Pain; Burn(s); Discomfort; Gastrointestinal Hemorrhage; Inflammation; Swelling/ Edema

  MAUDE report 23652294 ↗
• MalfunctionNov 25, 2025Leak/Splash; Leak/Splash

  ECN EVENT DESCRIPTION: SITUACIÓN QUE NOS REPORTAN EN SURA DE LAS SONDAS DE RECAMBIO ENFIT, HAN TENIDO MÁS DE 5 PCTES, LOS CUALES HAN PRESENTADO SANGRADO PERIOSTOMAL DESDE EL CAMBIO DE LAS SONDAS, FILTRACIONES, DAÑO DEL ESTOMA Y PIEL PERILESIONAL, ESTO NO HABÍA OCURRIDO ANTES Y SE HA VENIDO EVIDENCIANDO DESDE LAS COLOCACIONES DE SEPTIEMBRE, AGRADEZCO CON LATAM SI PUEDES VALIDAR SI HAN PRESENTADO UNA SITUACIÓN SIMILAR. COMPARTO EVIDENCIAS FOTOGRÁFICAS DE LOS CASOS SITUATION REPORTED TO US AT SURA REGARDING ENFIT REPLACEMENT TUBES: THEY HAVE HAD MORE THAN 5 PATIENTS WHO HAVE PRESENTED PERISTOMAL BLEEDING SINCE THE TUBE CHANGE, LEAKS, DAMAGE TO THE STOMA AND PERILESIONAL SKIN. THIS HAD NOT OCCURRED BEFORE AND HAS BEEN EVIDENT SINCE THE SEPTEMBER PLACEMENTS. I WOULD APPRECIATE IT IF LATAM COULD VALIDATE WHETHER THEY HAVE PRESENTED A SIMILAR SITUATION. I SHARE PHOTOGRAPHIC EVIDENCE OF THE CASES WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE? VALORACIÓN POR ESPECIALISTA - SPECIALIST ASSESSMENT WHAT IS THE NEXT COURSE OF ACTION? VALORACIÓN POR ESPECIALISTA - SPECIALIST ASSESSMENT PATIENT PRESENT AT TIME OF EVENT? YES, PATIENT COMPLICATIONS: DI

  Patient problems: Abdominal Pain; Burn(s); Discomfort; Gastrointestinal Hemorrhage; Inflammation; Swelling/ Edema

  MAUDE report 23652293 ↗
• MalfunctionNov 25, 2025Leak/Splash; Leak/Splash

  ECN EVENT DESCRIPTION: SITUACIÓN QUE NOS REPORTAN EN SURA DE LAS SONDAS DE RECAMBIO ENFIT, HAN TENIDO MÁS DE 5 PCTES, LOS CUALES HAN PRESENTADO SANGRADO PERIOSTOMAL DESDE EL CAMBIO DE LAS SONDAS, FILTRACIONES, DAÑO DEL ESTOMA Y PIEL PERILESIONAL, ESTO NO HABÍA OCURRIDO ANTES Y SE HA VENIDO EVIDENCIANDO DESDE LAS COLOCACIONES DE SEPTIEMBRE, AGRADEZCO CON LATAM SI PUEDES VALIDAR SI HAN PRESENTADO UNA SITUACIÓN SIMILAR. COMPARTO EVIDENCIAS FOTOGRÁFICAS DE LOS CASOS SITUATION REPORTED TO US AT SURA REGARDING ENFIT REPLACEMENT TUBES: THEY HAVE HAD MORE THAN 5 PATIENTS WHO HAVE PRESENTED PERISTOMAL BLEEDING SINCE THE TUBE. CHANGE, LEAKS, DAMAGE TO THE STOMA AND PERILESIONAL SKIN. THIS HAD NOT OCCURRED BEFORE AND HAS BEEN EVIDENT SINCE THE (B)(6) PLACEMENTS. I WOULD APPRECIATE IT IF LATAM COULD VALIDATE WHETHER THEY HAVE PRESENTED A SIMILAR SITUATION. I SHARE PHOTOGRAPHIC EVIDENCE OF THE CASES WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: VALORACIÓN POR ESPECIALISTA - SPECIALIST ASSESSMENT WHAT IS THE NEXT COURSE OF ACTION?: VALORACIÓN POR ESPECIALISTA - SPECIALIST ASSESSMENT PATIENT PRESENT AT TIME OF EVENT?: YES PATIENT COMPLICATIONS: DI

  Patient problems: Abdominal Pain; Burn(s); Discomfort; Gastrointestinal Hemorrhage; Inflammation; Swelling/ Edema

  MAUDE report 23652291 ↗
• MalfunctionNov 25, 2025Leak/Splash; Leak/Splash

  ECN EVENT DESCRIPTION: SITUACI6N QUE NOS REPORTAN EN SURA DE LAS SONDAS DE RECAMBIO ENFIT, HAN TENIDO MAS DE 5 PCTES, LAS CUALES HAN PRESENTADO SANGRADO PERIOSTOMAL DESDE EL CAMBIO DE LAS SONDAS, FILTRACIONES, DAI'IO DEL ESTOMA Y PIEL PERILESIONAL, ESTO NO HABIA OCURRIDO ANTES Y SE HA VENIDO EVIDENCIANDO DESDE LAS COLOCACIONES DE SEPTIEMBRE, AGRADEZCO CON LATAM SI PUEDES VALIDAR SI HAN PRESENTADO UNA SITUACI6N SIMILAR. COMPARTO EVIDENCIAS FOTOGRAFICAS DE LAS CASES SITUATION REPORTED TO US AT SURA REGARDING ENFIT REPLACEMENT TUBES: THEY HAVE HAD MORE THAN 5 PATIENTS WHO HAVE PRESENTED PERISTOMAL BLEEDING SINCE THE TUBE CHANGE, LEAKS, DAMAGE TO THE STOMA AND PERILESIONAL SKIN. THIS HAD NOT OCCURRED BEFORE AND HAS BEEN EVIDENT SINCE THE SEPTEMBER PLACEMENTS. I WOULD APPRECIATE IT IF LATAM COULD VALIDATE WHETHER THEY HAVE PRESENTED A SIMILAR SITUATION. I SHARE PHOTOGRAPHIC EVIDENCE OF THE CASES WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE? VALORACI6N PAR ESPECIALISTA - SPECIALIST ASSESSMENT WHAT IS THE NEXT COURSE OF ACTION? VALORACI6N PAR ESPECIALISTA - SPECIALIST ASSESSMENT PATIENT PRESENT AT TIME OF EVENT? YES PATIENT COMPLICATIONS: D

  Patient problems: Abdominal Pain; Burn(s); Discomfort; Gastrointestinal Hemorrhage; Inflammation; Swelling/ Edema

  MAUDE report 23649588 ↗
• MalfunctionNov 25, 2025Leak/Splash; Leak/Splash

  ECN EVENT DESCRIPTION: SITUACIÓN QUE NOS REPORTAN EN SURA DE LAS SONDAS DE RECAMBIO ENFIT, HAN TENIDO MÁS DE 5 PCTES, LOS CUALES HAN PRESENTADO SANGRADO PERIOSTOMAL DESDE EL CAMBIO DE LAS SONDAS, FILTRACIONES, DAÑO DEL ESTOMA Y PIEL PERILESIONAL, ESTO NO HABÍA OCURRIDO ANTES Y SE HA VENIDO EVIDENCIANDO DESDE LAS COLOCACIONES DE SEPTIEMBRE, AGRADEZCO CON LATAM SI PUEDES VALIDAR SI HAN PRESENTADO UNA SITUACIÓN SIMILAR. COMPARTO EVIDENCIAS FOTOGRÁFICAS DE LOS CASOS SITUATION REPORTED TO US AT SURA REGARDING ENFIT REPLACEMENT TUBES: THEY HAVE HAD MORE THAN 5 PATIENTS WHO HAVE PRESENTED PERISTOMAL BLEEDING SINCE THE TUBE CHANGE, LEAKS, DAMAGE TO THE STOMA AND PERILESIONAL SKIN. THIS HAD NOT OCCURRED BEFORE AND HAS BEEN EVIDENT SINCE THE SEPTEMBER PLACEMENTS. I WOULD APPRECIATE IT IF LATAM COULD VALIDATE WHETHER THEY HAVE PRESENTED A SIMILAR SITUATION. I SHARE PHOTOGRAPHIC EVIDENCE OF THE CASES WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: VALORACIÓN POR ESPECIALISTA - SPECIALIST ASSESSMENT WHAT IS THE NEXT COURSE OF ACTION?: VALORACIÓN POR ESPECIALISTA - SPECIALIST ASSESSMENT PATIENT PRESENT AT TIME OF EVENT?: YES PATIENT COMPLICATIONS:

  Patient problems: Abdominal Pain; Burn(s); Discomfort; Gastrointestinal Hemorrhage; Inflammation; Swelling/ Edema

  MAUDE report 23649211 ↗
• MalfunctionNov 25, 2025Leak/Splash; Leak/Splash

  ECN EVENT DESCRIPTION: SITUACIÓN QUE NOS REPORTAN EN SURA DE LAS SONDAS DE RECAMBIO ENFIT, HAN TENIDO MÁS DE 5 PCTES, LOS CUALES HAN PRESENTADO SANGRADO PERIOSTOMAL DESDE EL CAMBIO DE LAS SONDAS, FILTRACIONES, DAÑO DEL ESTOMA Y PIEL PERILESIONAL, ESTO NO HABÍA OCURRIDO ANTES Y SE HA VENIDO EVIDENCIANDO DESDE LAS COLOCACIONES DE SEPTIEMBRE, AGRADEZCO CON LATAM SI PUEDES VALIDAR SI HAN PRESENTADO UNA SITUACIÓN SIMILAR. COMPARTO EVIDENCIAS FOTOGRÁFICAS DE LOS CASOS SITUATION REPORTED TO US AT SURA REGARDING ENFIT REPLACEMENT TUBES: THEY HAVE HAD MORE THAN 5 PATIENTS WHO HAVE PRESENTED PERISTOMAL BLEEDING SINCE THE TUBE CHANGE, LEAKS, DAMAGE TO THE STOMA AND PERILESIONAL SKIN. THIS HAD NOT OCCURRED BEFORE AND HAS BEEN EVIDENT SINCE THE SEPTEMBER PLACEMENTS. I WOULD APPRECIATE IT IF LATAM COULD VALIDATE WHETHER THEY HAVE PRESENTED A SIMILAR SITUATION. I SHARE PHOTOGRAPHIC EVIDENCE OF THE CASES WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: VALORACIÓN POR ESPECIALISTA - SPECIALIST ASSESSMENT WHAT IS THE NEXT COURSE OF ACTION?: VALORACIÓN POR ESPECIALISTA - SPECIALIST ASSESSMENT PATIENT PRESENT AT TIME OF EVENT?: YES PATIENT COMPLICATIONS:

  Patient problems: Abdominal Pain; Burn(s); Discomfort; Gastrointestinal Hemorrhage; Inflammation; Swelling/ Edema

  MAUDE report 23647770 ↗