EndoVive Standard PEG Kit M00509050Recalls & reported problems
Boston Scientific Corporation · Percutaneous Endoscopic Gastrostomy Kit ENFit · Class 2
All models of EndoVive Standard PEG Kit (8)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729880486), received between Apr 30, 2021 and Apr 29, 2024 — classified as 5 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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 16, 2026.
Reports received per month
Recalls naming this device
- Feb 20, 2024Open, Classified
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
Z-1514-2024 · Root cause: Process design · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem4
- Break1
- Detachment of Device or Device Component1
Patient problems
- Unspecified Infection4
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryApr 29, 2024Break; Break
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PUSH METHOD WAS ATTEMPTED TO BE USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE GUIDEWIRE SNAPPED INSIDE THE PATIENT. PART OF THE WIRE DETACHED, AND THE DETACHED PIECE WAS SUCCESSFULLY RETRIEVED USING A SNARE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER STANDARD PEG KIT PUSH METHOD. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT AFTER THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19203292 ↗MalfunctionJul 7, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PUSH METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PLACEMENT PROCEDURE ON (B)(6) 2022. DURING PREPARATION, THE PEG TUBE DETACHED. THE PROCEDURE WAS COMPLETED WITH A NEW ENDOVIVE STANDARD PEG KIT PUSH METHOD. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14945872 ↗InjuryApr 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG PUSH METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. POST PROCEDURE, THE PATIENT WENT TO EMERGENCY ROOM FOR AN INCISION SITE INFECTION AND WAS TREATED WITH ANTIBIOTICS. NO ADDITIONAL INFORMATION HAS BEEN ABLE TO BE OBTAINED DESPITE GOOD FAITH EFFORTS.
Patient problems: Unspecified Infection
MAUDE report 11757233 ↗InjuryApr 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG PUSH METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. POST PROCEDURE, THE PATIENT WENT TO EMERGENCY ROOM FOR AN INCISION SITE INFECTION AND WAS TREATED WITH ANTIBIOTICS. NO ADDITIONAL INFORMATION HAS BEEN ABLE TO BE OBTAINED DESPITE GOOD FAITH EFFORTS.
Patient problems: Unspecified Infection
MAUDE report 11757204 ↗InjuryApr 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG PUSH METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. POST PROCEDURE, THE PATIENT WENT TO EMERGENCY ROOM FOR AN INCISION SITE INFECTION AND WAS TREATED WITH ANTIBIOTICS. NO ADDITIONAL INFORMATION HAS BEEN ABLE TO BE OBTAINED DESPITE GOOD FAITH EFFORTS.
Patient problems: Unspecified Infection
MAUDE report 11757198 ↗InjuryApr 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG PUSH METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. POST PROCEDURE, THE PATIENT WENT TO EMERGENCY ROOM FOR AN INCISION SITE INFECTION AND WAS TREATED WITH ANTIBIOTICS. NO ADDITIONAL INFORMATION HAS BEEN ABLE TO BE OBTAINED DESPITE GOOD FAITH EFFORTS.
Patient problems: Unspecified Infection
MAUDE report 11756649 ↗
Other Gastrointestinal Tubes with Enteral Specific Connectors devices
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- Salem Sump 8888264986ECardinal Health 200, LLC · Gastrointestinal Tubes with Enteral Specific Connectors1 recall1 death2 reports
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- 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
- EndoVive Safety PEG Kit M00509030Boston Scientific Corporation · Gastrointestinal Tubes with Enteral Specific Connectors13 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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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