EndoVive Safety PEG Kit M00509010Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 08714729880400), received between Nov 3, 2020 and Feb 5, 2025 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (11 reports).

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

Recalls naming this device

1. 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-1513-2024 · Root cause: Process design · FDA record ↗

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE PUSH PEG KIT BROKE AT THE CONNECTION AS THEY WERE PULLING IT THROUGH THE SKIN. THEY WERE ABLE TO GET A HOLD OF THE PLASTIC PIECE AND GRADUALLY WORKED IT THROUGH THE INCISION. IT WAS REPORTED THAT THE INCISION WAS ENLARGED. THE PLASTIC PIECE HOWEVER BROKE AGAIN IN TWO DIFFERENT PLACES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21318331 ↗
• MalfunctionJul 8, 2024Obstruction of Flow; Obstruction of Flow

  NOTE: THIS REPORT PERTAINS TO THREE ENDOVIVE SAFETY PEG KIT USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT WAS ATTEMPTED TO BE USED DURING PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE GUIDEWIRE WAS NOT ABLE TO ADVANCE THRU THE PEG TUBE DUE TO AN OCCLUSION. THE CUSTOMER REPORTED THAT TWO ADDITIONAL PEG KITS WERE OPENED AND ATTEMPTED TO BE USED BUT THE SAME PROBLEM OCCURRED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19690832 ↗
• MalfunctionJul 8, 2024Obstruction of Flow; Obstruction of Flow

  NOTE: THIS REPORT PERTAINS TO THREE ENDOVIVE SAFETY PEG KIT USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT WAS ATTEMPTED TO BE USED DURING PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE GUIDEWIRE WAS NOT ABLE TO ADVANCE THRU THE PEG TUBE DUE TO AN OCCLUSION. THE CUSTOMER REPORTED THAT TWO ADDITIONAL PEG KITS WERE OPENED AND ATTEMPTED TO BE USED BUT THE SAME PROBLEM OCCURRED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19690786 ↗
• MalfunctionJul 5, 2024Obstruction of Flow; Obstruction of Flow

  NOTE: THIS REPORT PERTAINS TO THREE ENDOVIVE SAFETY PEG KIT USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT WAS ATTEMPTED TO BE USED DURING PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE GUIDEWIRE WAS NOT ABLE TO ADVANCE THRU THE PEG TUBE DUE TO AN OCCLUSION. THE CUSTOMER REPORTED THAT TWO ADDITIONAL PEG KITS WERE OPENED AND ATTEMPTED TO BE USED BUT THE SAME PROBLEM OCCURRED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19684475 ↗
• MalfunctionMay 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS ATTEMPTED TO BE USED DURING PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING INSERTION, THE TUBE BROKE APART AT THE MIDDLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER 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 19354875 ↗
• MalfunctionMay 2, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS ATTEMPTED TO BE USED DURING PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO PASS THE WIRE THROUGH THE INTRODUCER. IT WAS REPORTED THAT THE TIP OF THE INTRODUCER WAS CLOGGED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER 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 19230451 ↗
• MalfunctionFeb 28, 2024Obstruction of Flow; Obstruction of Flow

  NOTE: THIS REPORT PERTAINS TO THE THIRD OF THREE ENDOVIVE SAFETY PEG KITS PUSH METHOD THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS ATTEMPTED TO BE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE GUIDEWIRE COULD NOT PASS THROUGH THE TRANSITION ZONE BETWEEN THE CONNECTOR, BETWEEN THE HARD AND SOFT PLASTIC. THE CUSTOMER REPORTED THAT TWO ADDITIONAL PEG KITS WERE OPENED AND ATTEMPTED TO BE USED BUT THE SAME PROBLEM OCCURRED. THE PROCEDURE WAS COMPLETED WITH A FOURTH ENDOVIVE SAFETY 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 18800174 ↗
• MalfunctionFeb 28, 2024Obstruction of Flow; Obstruction of Flow

  NOTE: THIS REPORT PERTAINS TO THE SECOND OF THREE ENDOVIVE SAFETY PEG KITS PUSH METHOD THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS ATTEMPTED TO BE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE GUIDEWIRE COULD NOT PASS THROUGH THE TRANSITION ZONE BETWEEN THE CONNECTOR, BETWEEN THE HARD AND SOFT PLASTIC. THE CUSTOMER REPORTED THAT TWO ADDITIONAL PEG KITS WERE OPENED AND ATTEMPTED TO BE USED BUT THE SAME PROBLEM OCCURRED. THE PROCEDURE WAS COMPLETED WITH A FOURTH ENDOVIVE SAFETY 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 18800154 ↗
• MalfunctionFeb 28, 2024Obstruction of Flow; Obstruction of Flow

  NOTE: THIS REPORT PERTAINS TO THE FIRST OF THREE ENDOVIVE SAFETY PEG KITS PUSH METHOD THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS ATTEMPTED TO BE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE GUIDEWIRE COULD NOT PASS THROUGH THE TRANSITION ZONE BETWEEN THE CONNECTOR, BETWEEN THE HARD AND SOFT PLASTIC. THE CUSTOMER REPORTED THAT TWO ADDITIONAL PEG KITS WERE OPENED AND ATTEMPTED TO BE USED BUT THE SAME PROBLEM OCCURRED. THE PROCEDURE WAS COMPLETED WITH A FOURTH ENDOVIVE SAFETY 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 18799508 ↗
• MalfunctionFeb 15, 2024Obstruction of Flow; Obstruction of Flow

  NOTE: THIS REPORT PERTAINS TO THE SECOND OF TWO ENDOVIVE SAFETY PEG KITS PUSH METHOD THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE GUIDEWIRE COULD NOT PASS THROUGH THE TRANSITION ZONE BETWEEN THE CONNECTOR, BETWEEN THE HARD AND SOFT PLASTIC. ANOTHER PEG KIT WAS USED; HOWEVER, THE SAME PROBLEM OCCURRED. THE PROCEDURE WAS COMPLETED WITH A THIRD ENDOVIVE SAFETY 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 18716080 ↗
• MalfunctionFeb 15, 2024Obstruction of Flow; Obstruction of Flow

  NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO ENDOVIVE SAFETY PEG KITS PUSH METHOD THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE GUIDEWIRE COULD NOT PASS THROUGH THE TRANSITION ZONE BETWEEN THE CONNECTOR, BETWEEN THE HARD AND SOFT PLASTIC. ANOTHER PEG KIT WAS USED; HOWEVER, THE SAME PROBLEM OCCURRED. THE PROCEDURE WAS COMPLETED WITH A THIRD ENDOVIVE SAFETY 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 18716071 ↗
• MalfunctionFeb 15, 2024Obstruction of Flow; Obstruction of Flow

  NOTE: THIS REPORT PERTAINS TO THE SECOND OF TWO ENDOVIVE SAFETY PEG KITS PUSH METHOD THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE GUIDEWIRE COULD NOT PASS THROUGH THE TRANSITION ZONE BETWEEN THE CONNECTOR, BETWEEN THE HARD AND SOFT PLASTIC. ANOTHER PEG KIT WAS USED; HOWEVER, THE SAME PROBLEM OCCURRED. THE PROCEDURE WAS COMPLETED WITH A THIRD ENDOVIVE SAFETY 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 18715536 ↗
• MalfunctionFeb 15, 2024Obstruction of Flow; Obstruction of Flow

  NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO ENDOVIVE SAFETY PEG KITS PUSH METHOD THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE GUIDEWIRE COULD NOT PASS THROUGH THE TRANSITION ZONE BETWEEN THE CONNECTOR, BETWEEN THE HARD AND SOFT PLASTIC. ANOTHER PEG KIT WAS USED; HOWEVER, THE SAME PROBLEM OCCURRED. THE PROCEDURE WAS COMPLETED WITH A THIRD ENDOVIVE SAFETY 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 18715209 ↗
• MalfunctionSep 21, 2023Break; Defective Device; Break; Defective Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PLACEMENT PROCEDURE PERFORMED ON (B)(6), 2023. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF A LOOP WIRE DISTAL END SECTION OF THE FEEDING TUBE WAS DETACHED. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17787638 ↗
• MalfunctionJan 26, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY WITH PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PLACEMENT PROCEDURE ON (B)(6) 2022. DURING THE PROCEDURE, THE PEG TUBE DETACHED AT THE TRANSITION ZONE BETWEEN THE HARD AND SOFT PLASTIC. THE PROCEDURE WAS COMPLETED WITH A NEW ENDOVIVE SAFETY 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 13360276 ↗
• InjuryNov 3, 2020Use of Device Problem; Difficult to Advance; Use of Device Problem; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ENDOVIVE SAFETY PEG KIT PULL METHOD USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PEG TUBE WAS DIFFICULT TO PULL THROUGH THE STOMA. THE PHYSICIAN INTRODUCED THE TROCAR HOWEVER AN INITIAL INCISION WAS NOT DONE FIRST. REPORTEDLY, PROBLEMS BEGAN WHEN INCISIONS WERE MADE ALONGSIDE THE TUBING WHILE TRYING TO PULL THE TUBE THROUGH THE SITE. THIS CREATED SEVERAL MICRO PERFORATIONS. THE PATIENT WENT TO SURGERY. PER PHYSICIAN ASSESSMENT, THE PEG TUBE CONTRIBUTE TO THE MICRO PERFORATIONS. THE IFU (INSTRUCTIONS FOR USE) ENDOVIVE SAFETY PEG KIT PULL METHOD FOURTH STEP STATES THE FOLLOWING: USING THE EXPOSED BLADE OF THE SAFETY SCALPEL PROVIDED, MAKE A 1 TO 1.5 CM INCISION AT THE SELECTED INCISION SITE.

  Patient problems: No Code Available; Perforation

  MAUDE report 10777112 ↗