EndoVive Safety PEG KitRecalls & reported problems across all models
Boston Scientific Corporation · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
3 open recalls name at least one EndoVive Safety PEG Kit model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 270
- Deaths reported
- 3
- Injuries reported
- 37
- Recalls
- 3
We found 8 models of EndoVive Safety PEG Kit by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 270 adverse event reports in the FDA's MAUDE database, received between Nov 11, 2016 and Sep 18, 2026 — classified as 3 deaths, 37 injuries, 230 malfunctions.
The most frequently reported specific device problem is “Obstruction of Flow” (98 reports).
3 FDA recall records name at least one of these models by its device identifier, 3 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
EndoVive Safety PEG Kit recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Feb 10, 2026Open, Classified
Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on the sterile swabstick packaging, which could result in loss of sterility or drying of the antiseptic solution. This component is placed outside of the sterile barrier of the tray manufactured by Boston Scientific, which contains the majority of the kit components. As such, inclusion of the affected ChloraPrep Triple Swabsticks does not degrade the integrity of the other components within the PEG kit.
Z-1551-2026 · Root cause: Process control · Recall details · FDA record ↗
- 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-1515-2024 · Root cause: Process design · Recall details · FDA record ↗
- 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 · Recall details · FDA record ↗
Most reported EndoVive Safety PEG Kit problems
Device problems
- Obstruction of Flow98
- Detachment of Device or Device Component63
- Break42
- Detachment Of Device Component20
- Device Dislodged or Dislocated20
- Difficult to Advance15
- Adverse Event Without Identified Device or Use Problem6
- Defective Device4
Patient problems
- No Clinical Signs, Symptoms or Conditions189
- No Consequences Or Impact To Patient64
- No Known Impact Or Consequence To Patient9
- Death2
- No Code Available2
- No Patient Involvement2
- Peritonitis2
- Abdominal Pain1
EndoVive Safety PEG Kit models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- EndoVive Safety PEG Kit M00566470TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 recall1 death111 reports
- EndoVive Safety PEG Kit M00509000Gastrointestinal Tubes with Enteral Specific Connectors1 recall32 reports
- EndoVive Safety PEG Kit M00509010Gastrointestinal Tubes with Enteral Specific Connectors1 recall16 reports
- EndoVive Safety PEG Kit M00566460TUBES, GASTROINTESTINAL (AND ACCESSORIES)53 reports
- EndoVive Safety PEG Kit M00566490TUBES, GASTROINTESTINAL (AND ACCESSORIES)2 deaths32 reports
- EndoVive Safety PEG Kit M00509030Gastrointestinal Tubes with Enteral Specific Connectors13 reports
- EndoVive Safety PEG Kit M00566480TUBES, GASTROINTESTINAL (AND ACCESSORIES)7 reports
- EndoVive Safety PEG Kit M00509020Gastrointestinal Tubes with Enteral Specific Connectors6 reports
Recent EndoVive Safety PEG Kit adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50828056 ↗MalfunctionAug 25, 2026Break
It was reported to Boston Scientific Corporation that an EndoVive Safety PEG Kit Pull Method was used in the upper GI tract during an Esophagogastroduodenoscopy (EGD) with placement of a PEG procedure to treat cancer performed on (b)(6) 2026.During the procedure, there was a Pull PEG being place on a patient as they were passing the peg portion and pulling it through the patient, the metal cable snapped/sheered. Luckly there was small portion of the bed that came out of the opening in the stomach that allowed the doctor to fully pull it through. The procedure was completed with the same original device. 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 stable.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50423134 ↗MalfunctionJul 20, 2026Difficult to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25883980 ↗MalfunctionJul 20, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25883978 ↗InjuryMay 21, 2026Break
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED IN THE STOMACH DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, WHEN THEY WERE PULLING THE PEG TUBE THROUGH THE INCISION, THE WIRE SNAPPED. THERE WAS ENOUGH LEFT OVER THAT THE PHYSICIAN WAS ABLE TO GRAB THE WIRE THAT WAS CONNECTED TO THE TIP OF THE PEG WITH A PAIR OF HEMOSTATS AND GUIDE THE TUBE THE REST OF THE WAY THROUGH THE INCISION. IT WAS REPORTED THAT THEY COMPLETED MOST OF THE PROCEDURE WHEN THE PROBLEM OCCURRED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION WAS EXPECTED TO BE FULLY RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25243949 ↗MalfunctionApr 30, 2026Break
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED IN THE STOMACH DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, WHEN THE PHYSICIAN USED THE SNARE TO PULL THE WIRE THROUGH THE ESOPHAGUS OF THE PATIENT, IT WAS REPORTED THAT THE WIRE SEPARATED (BROKE) AWAY FROM SNARE. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL ENDOVIVE SAFETY PEG USING AN ALTERNATE DEVICE TO PULL AND PLACE THE PEG TUBE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25049666 ↗InjuryMar 25, 2026Break
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED IN THE STOMACH DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, AFTER THE NURSE COMPLETED THE CUT SITE, THE PHYSICIAN ADVANCED THE WIRE AND PASSED THE PULL WIRE THROUGH THE PEG TUBE AS USUAL. THE PEG WAS THEN PULLED DOWN THROUGH THE ESOPHAGUS AND INTO THE STOMACH. WHEN ATTEMPTING TO PULL THE PEG THROUGH THE GASTRIC WALL AND INTO THE STOMACH, THE LOOPED PULL WIRE AT THE TIP OF THE PEG BROKE. USING HEMOSTATS, THE TEAM WAS ABLE TO GRASP THE BROKEN PULL WIRE AT THE TIP OF THE PEG AND SUCCESSFULLY COMPLETE PLACEMENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FULLY RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24694408 ↗MalfunctionMar 10, 2026Device Contaminated During Manufacture or Shipping
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS UNPACKED ON FEBRUARY 09, 2026. IT WAS REPORTED THAT THERE WAS A PIECE OF HAIR INSIDE THE PACKAGING. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWS A HAIR-LIKE PARTICLE ON THE DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24559713 ↗MalfunctionDec 23, 2025Break; Break
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED IN THE STOMACH DURING A PEG TUBE PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHILE PULLING THE WIRE THROUGH THE BOLSTER, THE WIRE EXITED THE STOMACH AND SUBSEQUENTLY SNAPPED. THE CLINICAL TEAM WAS ABLE TO RETRIEVE THE WIRE AND COMPLETE THE DEPLOYMENT USING THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23884493 ↗MalfunctionDec 16, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS UNPACKED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PROCEDURE PERFORMED ON (B)(6) 2025. DURING PREPARATION, A HAIR WAS SEEN IN THE PACKAGE NEAR SNARE HANDLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23823483 ↗MalfunctionDec 2, 2025Break; Break
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED IN THE GASTRIC DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHILE TRANSFERRING THE PEG TUB FROM INSIDE THE STOMACH OUTSIDE OF THE STOMA SITE. THE NITINOL WIRE THAT IS ATTACHED TO THE PEG TUB, SNAPPED. THUS, NOT ALLOWING ENOUGH ROOM TO PULL THE TUB OUT AND HAVING TO REMOVE THE TUB FROM THE PATIENT. THE PROCEDURE WAS 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 23697560 ↗MalfunctionNov 5, 2025Break; Break
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED IN THE STOMACH DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE TO PROVIDE NUTRITIONAL SUPPORT PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE WIRE BROKE DURING PULL PORTION. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THAT THE PULL WIRE WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER 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 23473070 ↗MalfunctionAug 12, 2025Break; Break
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS ATTEMPTED TO BE USED IN THE STOMACH DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, WHEN PULLING THE PEG TUBE INTO POSITION, THE WIRE THAT IS USED TO PULL THE PEG TUBE BROKE. IT WAS REPORTED THAT NO PART OF THE WIRE DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER 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 22786343 ↗MalfunctionAug 5, 2025Break; Break
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS ATTEMPTED TO BE USED IN THE STOMACH DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. THE SPECIFIC DATE IS UNKNOWN. DURING THE PROCEDURE, THE PHYSICIAN PLACED A PEG TUBE AND THE WIRE LOOP (WHILE ATTACHED TO THE PEG TUBE) COMPLETELY SNAPPED OFF WHEN THE PHYSICIAN WAS TRYING TO PULL THE PEG TUBE THROUGH THE INCISION. THE PHYSICIAN ATTEMPTED TO USE A HEMOSTAT TO PULL THE PART OF THE TUBE STILL COMING OUT OF THE PATIENT AND THE REST OF THE WIRE BROKE OFF. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THAT THE LOOP WIRE WAS BROKEN AND WAS DETACHED FROM THE CONNECTING WIRE. IT WAS REPORTED THAT NO PART OF THE DEVICE DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER 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 22719719 ↗InjuryJul 15, 2025Entrapment of Device; Entrapment of Device
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED IN THE STOMACH DURING AN INITIAL PEG (PERCUTANEOUS ENDOSCOPIC GASTROSTOMY) TUBE PLACEMENT PROCEDURE. THE EXACT PROCEDURE DATE WAS UNKNOWN. DURING THE PROCEDURE, IT WAS INCREASINGLY DIFFICULT TO REMOVE THE BUMPER. IT WAS REPORTED THAT THE PHYSICIAN HAD TO SCHEDULE THE PATIENT FOR EGD (ESOPHAGOGASTRODUODENOSCOPY) TO REMOVE THE PEG TUBE INTERNALLY BECAUSE IT WAS DIFFICULT TO REMOVE BY HAND VIA TRACTION. IT WAS ALSO REPORTED THAT LOCAL ANESTHESIA WAS GIVEN DURING TRACTION REMOVAL ATTEMPTS AND THE EGD REMOVAL WAS SUCCESSFULLY COMPLETED. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THE PATIENT WAS REPORTED TO HAVE FULLY RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22509282 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- 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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