EndoVive Standard 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
2 open recalls name at least one EndoVive Standard PEG Kit model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 95
- Deaths reported
- 1
- Injuries reported
- 31
- Recalls
- 2
We found 8 models of EndoVive Standard PEG Kit by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 95 adverse event reports in the FDA's MAUDE database, received between Apr 6, 2017 and Jan 13, 2026 — classified as 1 death, 31 injuries, 63 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (35 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 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 Standard 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 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-1516-2024 · 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-1514-2024 · Root cause: Process design · Recall details · FDA record ↗
Most reported EndoVive Standard PEG Kit problems
Device problems
- Detachment of Device or Device Component35
- Device Dislodged or Dislocated14
- Difficult to Advance12
- Break10
- Obstruction of Flow9
- Adverse Event Without Identified Device or Use Problem8
- Defective Device3
- Deformation Due to Compressive Stress3
Patient problems
- No Clinical Signs, Symptoms or Conditions64
- No Consequences Or Impact To Patient15
- Unspecified Infection4
- No Known Impact Or Consequence To Patient3
- Insufficient Information2
- No Patient Involvement2
- Perforation2
- Peritonitis2
EndoVive Standard PEG Kit models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- EndoVive Standard PEG Kit M00568210TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 recall28 reports
- EndoVive Standard PEG Kit M00509050Gastrointestinal Tubes with Enteral Specific Connectors1 recall6 reports
- EndoVive Standard PEG Kit M00568200TUBES, GASTROINTESTINAL (AND ACCESSORIES)33 reports
- EndoVive Standard PEG Kit M00568250TUBES, GASTROINTESTINAL (AND ACCESSORIES)8 reports
- EndoVive Standard PEG Kit M00509070Gastrointestinal Tubes with Enteral Specific Connectors7 reports
- EndoVive Standard PEG Kit M00509040Gastrointestinal Tubes with Enteral Specific Connectors1 death6 reports
- EndoVive Standard PEG Kit M00509060Gastrointestinal Tubes with Enteral Specific Connectors4 reports
- EndoVive Standard PEG Kit M00568240TUBES, GASTROINTESTINAL (AND ACCESSORIES)3 reports
Recent EndoVive Standard PEG Kit adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJan 13, 2026Deformation Due to Compressive Stress; Difficult to Advance
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PUSH METHOD WAS USED IN THE STOMACH DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, WHEN ADVANCING THE PEG TUBE OVER WIRE, THE PLASTIC KINKS WHEN TRYING TO PUSH THROUGH INCISION SITE. TO COMPLETE THE PROCEDURE, THE TRACT WAS DILATED THEN THE DEVICE WAS ADVANCE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24064210 ↗InjuryJan 13, 2026Deformation Due to Compressive Stress; Difficult to Advance
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PUSH METHOD WAS USED IN THE STOMACH DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, WHEN ADVANCING THE PEG TUBE OVER WIRE, THE PLASTIC KINKS WHEN TRYING TO PUSH THROUGH INCISION SITE. TO COMPLETE THE PROCEDURE, THE TRACT WAS DILATED THEN THE DEVICE WAS ADVANCE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24064207 ↗InjuryJan 9, 2026Deformation Due to Compressive Stress; Difficult to Advance
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PUSH METHOD WAS USED IN THE STOMACH DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN ADVANCING THE PEG TUBE OVER WIRE, THE PLASTIC KINKS WHEN TRYING TO PUSH THROUGH INCISION SITE. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THE INSERTION TUBE DEVICE WITH SEVERAL KINKS. TO COMPLETE THE PROCEDURE, THE TRACT WAS DILATED THEN THE DEVICE WAS ADVANCE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24027614 ↗InjuryDec 30, 2025Break; Break
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PULL METHOD WAS USED IN THE ABDOMEN DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) FOR ESOPHAGEAL CANCER WITH DYSPHAGIA AND WEIGHT LOSS PERFORMED ON (B)(6) 2025. DURING THE PEG TUBE PLACEMENT PROCEDURE, THE WIRE USED TO PULL THE TUBE THROUGH THE STOMACH SNAPPED AND BROKE. THE DEVICE WAS COMPLETELY REMOVED, AND A NEW PEG TUBE WAS INSERTED. DUE TO THE PROBLEM ENCOUNTERED, THE PATIENT REQUIRED SURGICAL INTERVENTION. THE PATIENT PROCEEDED TO SURGERY FOR FURTHER MANAGEMENT. THE PATIENT HAD NO IMMEDIATE COMPLICATIONS, AND THE PATIENT CONDITION WAS REPORTED TO BE STABLE AT THE CONCLUSION OF THE PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 23926919 ↗InjuryNov 17, 2025Difficult to Advance; Difficult to Advance
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PULL METHOD WAS ATTEMPTED TO BE USED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SURGEON COULD NOT GET THE DEVICE TO SLIDE OR OPERATE AT ALL. THE PEG ITSELF WAS NOT WORKING PROPERLY CAUSING THE SURGEON TO REQUEST A NEW ONE. ADDITIONAL CLARIFICATION REGARDING THE NATURE OF THE SERIOUS INJURY OR THE TYPE OF REQUIRED INTERVENTION WAS NOT PROVIDED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.
Patient problems: Insufficient Information
MAUDE report 23566442 ↗MalfunctionMay 29, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PULL METHOD WAS INSPECTED ON MAY 6, 2025. UPON INSPECTION, IT WAS REPORTED THAT A HAIR WAS INSIDE THE UNOPENED, STERILE DEVICE POUCH. IT WAS REPORTED THAT THERE WAS NO VISIBLE DAMAGE NOTED TO THE PACKAGING OF THE DEVICE. THERE WAS NO PATIENT OR PROCEDURE INVOLVED IN THIS EVENT. NOTE: A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWS A HAIR-LIKE PARTICLE ON THE TUBING OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22106471 ↗InjuryMay 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE TUBE BROKE WHILE BEING PULLED THROUGH THE ANTERIOR ABDOMINAL WALL. PART OF THE TUBE WAS LEFT IN THE PATIENT'S STOMACH. A LAPAROTOMY WAS PERFORMED TO RETRIEVE THE BROKEN TUBE AND PLACED A GASTROSTOMY TUBE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21969567 ↗MalfunctionFeb 20, 2025Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation
NOTE: THIS REPORT PERTAINS TO ONE OF TWO ENDOVIVE STANDARD PEG KIT PUSH METHODS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PUSH METHOD WAS USED IN THE STOMACH DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE FIRST PEG TUBE CORKSCREWED AT THE BOTTOM AND THE PHYSICIAN WAS UNABLE TO ADVANCE THE TUBE ALONG THE WIRE AND INTO THE PATIENT. THE 2ND PEG TUBE BROKE IN HALF WHEN THE PHYSICIAN WAS PULLING IT THROUGH THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER 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 21422547 ↗MalfunctionFeb 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
NOTE: THIS REPORT PERTAINS TO ONE OF TWO ENDOVIVE STANDARD PEG KIT PUSH METHODS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PUSH METHOD WAS USED IN THE STOMACH DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE FIRST PEG TUBE CORKSCREWED AT THE BOTTOM AND THE PHYSICIAN WAS UNABLE TO ADVANCE THE TUBE ALONG THE WIRE AND INTO THE PATIENT. THE 2ND PEG TUBE BROKE IN HALF WHEN THE PHYSICIAN WAS PULLING IT THROUGH THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER 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 21417350 ↗MalfunctionJan 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE PEG TUBE CAME APART DURING PLACEMENT. THE PHYSICIAN WAS ABLE TO GRASP THE PLASTIC TIP AND PULL THE TUBING THROUGH. A PHOTO OF THE DEVICE WAS PROVIDED BY THE CUSTOMER AND SHOWED THAT THE TRANSITION JOINT BETWEEN THE PEG TUBE AND THE INTRODUCER DILATOR WAS SEPARATED. THE PROCEDURE WAS COMPLETED WITH 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 21280405 ↗InjuryJan 16, 2025Material Separation; Material Separation
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PULL METHOD WAS USED IN A PROCEDURE. THE EXACT PROCEDURE DATE WAS UNKNOWN. DURING THE PROCEDURE, BEFORE CLOSING THE INCISION, THEY NOTICED THE WHITE SHEATH COVER OF THE NEEDLE AND THE ORANGE HUB (ALL ONE PIECE USED AS TROCAR) HAD DETACHED AND COME OUT IN THE PERITONEUM OF THE PATIENT. AN ATTEMPT WAS MADE TO REMOVE IT FROM THE PATIENT, BUT IT WAS UNSUCCESSFUL. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY WHERE THE DETACHED PIECE WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. **ADDITIONAL INFORMATION RECEIVED JANUARY 29, 2025** IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INTERVENTIONAL RADIOLOGY PROCEDURE AND RETURNED TO THE NURSING HOME WITH NO INCISION OR DRESSING TO THE ABDOMEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21173323 ↗InjuryOct 2, 2024Break; Break
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PULL METHOD WAS USED IN THE STOMACH DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH PEG PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, MODERATE SEDATION WAS APPLIED TO THE PATIENT. IT WAS OBSERVED THAT THE PULL WIRE BROKE OFF AS IT WAS PULLED THROUGH THE INCISION. THE PHYSICIAN WAS UNABLE TO COMPLETE THE PROCEDURE, AND THE PEG TUBE REMAINED INSIDE THE PATIENT. THE PATIENT WAS TRANSFERRED TO A SHORT-TERM ACUTE CARE (STAC) HOSPITAL AND THE SAME PHYSICIAN COMPLETED THE PROCEDURE UNDER GENERAL ANESTHESIA. THE PEG TUBE WAS REMOVED AND REPLACED WITH A NEW PEG TUBE. IT WAS REPORTED THAT THE PATIENT WAS OKAY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT ENDOVIVE STANDARD PEG KIT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20352350 ↗MalfunctionSep 27, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE. THE EXACT PROCEDURE DATE WAS UNKNOWN. POST PROCEDURE, THE PEG TUBE THAT THE PHYSICIAN PLACED WAS DISLODGED. 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 20325140 ↗MalfunctionJul 10, 2024Detachment 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 ATTEMPTED TO BE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. UPON INSERTION OF THE PEG TUBE, THE PLASTIC PART OF THE PEG TUBE/DRAIN CAME APART INTO TWO PIECES OUTSIDE OF THE PATIENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. DURING THE PROCEDURE, PEG (PERCUTANEOUS ENDOSCOPIC GASTROSTOMY) TUBE WAS PLACED TO THE PATIENT. UPON INSERTION, THE PLASTIC PART OF THE PEG TUBE/DRAIN CAME APART INTO TWO PIECES OUTSIDE OF THE PATIENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19714929 ↗MalfunctionMay 9, 2024Break; Break
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE PLACEMENT PROCEDURE. THE EXACT PROCEDURE DATE WAS UNKNOWN. DURING THE PROCEDURE, THE PULL WIRE INSIDE THE TUBE BROKE. 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 19283068 ↗
Other Boston Scientific Corporation products
- INGEVITY MRI7 models · 16,601 reports
- INGEVITY+3 models · 16,054 reports
- EMBLEM S-ICD4 models · 13,295 reports · 1 recall
- WATCHMAN25 models · 8,024 reports · 6 recalls
- AMS 800 Artificial Urinary Sphincter31 models · 7,515 reports · 2 recalls
- ENDOTAK RELIANCE SG9 models · 6,540 reports · 2 recalls
- RELIANCE 4-FRONT11 models · 5,739 reports
- FINELINE II EZ Sterox6 models · 5,633 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page