EndoVive Safety PEG Kit M00566460Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 08714729748380), received between Feb 21, 2017 and Oct 1, 2024 — classified as 13 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (16 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 53 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 1, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED DURING A PEG (PERCUTANEOUS ENDOSCOPIC GASTROSTOMY) TUBE PLACEMENT PROCEDURE PERFORMED IN (B)(6) 2024. DURING THE PROCEDURE, THE WIRE WAS PULLED THROUGH THE ABDOMEN AND THE WIRE BROKE IN THE HAND OF THE OPERATOR. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20347738 ↗
• MalfunctionSep 27, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS ATTEMPTED TO BE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE SNARE LOOP ON THE END OF THE PEG TUBE SNAPPED OFF. THE DEVICE WAS REMOVED FROM THE PATIENT AND NO BROKEN PARTS WERE LEFT BEHIND. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT AND WAS RESCHEDULED AS NO ALTERNATIVE DEVICE WAS AVAILABLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20323723 ↗
• MalfunctionSep 11, 2024

  PROCEDURALIST WAS PERFORMING A PEG REPLACEMENT AND UPON PULLING THE PEG THROUGH THE ABDOMEN APPROPRIATELY, THE WIRE BROKE IN HIS HAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20189047 ↗
• MalfunctionApr 16, 2024Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS ATTEMPTED TO BE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE. THE PROCEDURE DATE WAS UNKNOWN. DURING THE PROCEDURE, WHEN THE USER PULLED THE G-TUBE THROUGH THE ABDOMEN, THE PULL WIRE BROKE. THE PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY WITH THE ORIGINAL PEG KIT PULL METHOD. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19120578 ↗
• MalfunctionJan 5, 2024Component Missing; Obstruction of Flow; Component Missing; Obstruction of Flow

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) OR PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. IT WAS REPORTED THAT DURING TUBE PLACEMENT, THE NURSE WAS UNAWARE OF THE MISSING COMPONENT ON THE Y-PORT, UPON INSERTION, THE PEG TUBE BECAME OBSTRUCTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18460074 ↗
• InjuryDec 12, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. IT WAS REPORTED THAT, DURING DEVICE PLACEMENT, THE PEG TUBE BROKE OFF WHEN PULLING THROUGH THE STOMACH WALL. ADDITIONALLY, THE DETACHED PORTION WERE RETRIEVED. THE PROCEDURE WAS COMPLETED WITH A NEW ENDOVIVE STANDARD PEG KIT PULL METHOD. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18310996 ↗
• InjuryOct 26, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. IT WAS REPORTED THAT, DURING DEVICE PLACEMENT, THE PEG TUBE TIP DETACHED INTO THE PATIENT BETWEEN THE PERITONEAL AND THE STOMACH CAUSING AIR TO ENTER THE PATIENT. THE DEVICE WAS REMOVED ON (B)(6) 2023 AND THE PATIENT HAD TO UNDERGO AN X-LAP SURGICAL PROCEDURE TO REMOVE THE DETACHED TIP. THE CUSTOMER REPORTED THAT THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND EXPECTED TO FULLY RECOVER. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE AND NO FURTHER DEVICES WERE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18012465 ↗
• MalfunctionOct 12, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PLACEMENT PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. IT WAS REPORTED THAT, DURING DEVICE PLACEMENT, THE PEG TUBE DETACHED WHEN PULLING THROUGH THE STOMACH WALL. THE PROCEDURE WAS COMPLETED WITH A NEW ENDOVIVE SAFETY PEG KIT PULL METHOD. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17923308 ↗
• MalfunctionAug 9, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY WITH PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE PLACEMENT PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, WHEN THE PHYSICIAN WAS PULLING OUT THE TUBE FROM THE STOMACH TO THE SURFACE OF THE SKIN, THE LOOP WIRE BROKE. THE PROCEDURE WAS COMPLETED WITH THE SAME ORIGINAL ENDOVIVE SAFETY PEG KIT PULL METHOD. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17487281 ↗
• InjuryApr 20, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PLACEMENT PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. POST PROCEDURE, THE PEG TUBE BECAME DISLODGED. THE DEVICE WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16776899 ↗
• InjuryApr 20, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PLACEMENT PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. POST PROCEDURE, THE PEG TUBE BECAME DISLODGED. THE DEVICE WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16776891 ↗
• InjuryApr 20, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PLACEMENT PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. POST PROCEDURE, THE PEG TUBE BECAME DISLODGED. THE DEVICE WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16776851 ↗
• InjuryApr 19, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PLACEMENT PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. POST PROCEDURE, THE PEG TUBE BECAME DISLODGED AND CAUSED AN INFECTION IN THE STOMACH. THE DEVICE WAS REMOVED (B)(6) 2023. IT WAS REPORTED THAT THE PATIENT WAS GIVEN AN ANTIBIOTIC TO RESOLVE THE INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 16772330 ↗
• MalfunctionJun 30, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PLACEMENT PROCEDURE ON (B)(6) 2022. DURING THE PROCEDURE, PEG TUBE BECAME DISLODGED AND CAME OUT OF THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14875858 ↗
• MalfunctionJun 8, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PLACEMENT PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. IT WAS REPORTED POST PROCEDURE, THE PEG TUBE BECAME DISLODGED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14630717 ↗
• MalfunctionJun 7, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PLACEMENT PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. IT WAS REPORTED POST PROCEDURE, THE PEG TUBE BECAME DISLODGED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14626922 ↗
• MalfunctionJun 7, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PLACEMENT PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. IT WAS REPORTED POST PROCEDURE, THE PEG TUBE BECAME DISLODGED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14626793 ↗
• MalfunctionJun 7, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PLACEMENT PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. IT WAS REPORTED POST PROCEDURE, THE PEG TUBE BECAME DISLODGED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14626790 ↗
• MalfunctionJun 7, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PLACEMENT PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. IT WAS REPORTED POST PROCEDURE, THE PEG TUBE BECAME DISLODGED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14626735 ↗
• MalfunctionJun 7, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PLACEMENT PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. IT WAS REPORTED POST PROCEDURE, THE PEG TUBE BECAME DISLODGED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14626721 ↗
• MalfunctionJun 7, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PLACEMENT PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. IT WAS REPORTED POST PROCEDURE, THE PEG TUBE BECAME DISLODGED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14626611 ↗
• MalfunctionJun 7, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PLACEMENT PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. IT WAS REPORTED POST PROCEDURE, THE PEG TUBE BECAME DISLODGED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14626579 ↗
• MalfunctionJun 7, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PLACEMENT PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. IT WAS REPORTED POST PROCEDURE, THE PEG TUBE BECAME DISLODGED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14626522 ↗
• MalfunctionJun 6, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PLACEMENT PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. IT WAS REPORTED POST PROCEDURE, THE PEG TUBE BECAME DISLODGED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14604098 ↗
• MalfunctionJan 13, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG PULL METHOD WAS PLACED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, WHILE THE PEG TUBE WAS BEING PULLED THROUGH THE INCISION SITE, THE TUBE SEPARATED. THE PHYSICIAN WAS ABLE TO REATTACH THE TUBE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11158782 ↗