Ponsky PEG Safety System 006035Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00801741081187), received between Mar 10, 2017 and Feb 16, 2022 — classified as 2 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Fracture” (7 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 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2022Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED THAT SOMETIME POST FEEDING DEVICE PLACEMENT PROCEDURE, THE INTERNAL BUMPER OF THE DEVICE ALLEGEDLY DETACHED AND THE TUBE CAME OFF WHEN THE DEVICE WAS TRIED TO BE USED, THE INTERNAL BUMPER WAS REPORTED TO HAVE BEEN EXCRETED WITH THE STOOL. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13539955 ↗
• MalfunctionNov 1, 2021Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED THAT SIX MONTHS POST DEVICE IMPLANT, THE INTERNAL BUMPER WAS ALLEGEDLY BROKEN AND WAS FOUND TO BE INSIDE THE STOMACH. IT WAS FURTHER REPORTED THAT THE BUMPER WAS REMOVED USING AN ENDOSCOPY PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12726032 ↗
• MalfunctionSep 20, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT POST DEVICE PLACEMENT, THE FEEDING ADAPTER OF THE TUBE ALLEGEDLY CAME OFF. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12493713 ↗
• MalfunctionAug 31, 2021Blocked Connection; Blocked Connection

  IT WAS REPORTED THAT APPROXIMATELY ONE MONTH POST CATHETER IMPLANT, THE FEEDING ADAPTER ALLEGEDLY HAD DIFFICULTY CONNECTING WITH THE ENTERAL NUTRITION. THE DEVICE WAS REPORTED TO BE EXPLANTED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12390247 ↗
• MalfunctionJul 30, 2021Loss of or Failure to Bond; Fracture; Material Separation; Detachment of Device or Device Component; Loss of or Failure to Bond; Fracture; Material Separation; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE APPROXIMATELY SEVEN MONTHS POST FEEDING DEVICE IMPLANT, THE INTERNAL BUMPER ALLEGEDLY DETACHED. IT WAS FURTHER REPORTED THAT THE INTERNAL BUMPER WAS REMOVED USING AN ENDOSCOPE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12253338 ↗
• MalfunctionJun 7, 2021Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING THE DEVICE REMOVAL PROCEDURE, THE DEVICE WAS ALLEGEDLY BROKEN AND REMAINED IN THE STOMACH. IT WAS FURTHER REPORTED PART WAS REMOVED USING AN ENDOSCOPE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11945014 ↗
• InjuryJun 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE FEEDING TUBE PLACEMENT PROCEDURE, THE TRANSVERSE COLON WAS ALLEGEDLY PERFORATED AND RESULTING IN TRANSVERSE COLON FISTULA. IT WAS FURTHER REPORTED THAT THE CATHETER WAS REMOVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Bowel Perforation; Fistula

  MAUDE report 11918983 ↗
• MalfunctionMar 24, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT SOME TIME POST FEEDING TUBE PLACEMENT DURING EXCHANGING THE CATHETER, THE BUMPER ALLEGEDLY CAME OFF. IT WAS FURTHER REPORTED THAT THE BUMPER LEFT IN THE PATIENT BODY WAS REMOVED USING ENDOSCOPE. THE HEALTH INJURY TO THE PATIENT WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11559287 ↗
• MalfunctionDec 24, 2020Fracture; Malposition of Device; Fracture; Malposition of Device

  IT WAS REPORTED THAT APPROXIMATELY 34 DAYS POST FEEDING TUBE PLACEMENT, THE CATHETER WAS ALLEGEDLY FOUND PENETRATED TRANSVERSE COLON. IT WAS FURTHER REPORTED THAT DEVICE WAS USED MULTIPLE TIMES. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11070916 ↗
• MalfunctionDec 1, 2020Peeled/Delaminated; Deformation Due to Compressive Stress; Peeled/Delaminated; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING A FEEDING DEVICE PLACEMENT PROCEDURE, THE SURFACE OF THE WIRE WAS ALLEGEDLY FOUND PEELED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10926749 ↗
• MalfunctionNov 26, 2020Component Missing; Component Missing

  IT WAS REPORTED THAT THE UPON OPENING THE PORT DEVICE PACKAGE, THE FORCEPS WAS ALLEGEDLY MISSING IN THE KIT. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10910778 ↗
• MalfunctionNov 12, 2020Fracture; Fracture

  IT WAS REPORTED THAT POST IMPLANTED PROCEDURE APPROXIMATELY, THE DEVICE ALLEGEDLY BROKEN. IT WAS FURTHER REPORTED THAT DEVICE WAS REMOVED FROM THE PATIENT. THERE WAS NO REPORTED ON PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10827394 ↗
• MalfunctionNov 2, 2020Illegible Information; Illegible Information

  IT WAS REPORTED THAT TWENTY-FOUR DAYS POST GASTROSTOMY FEEDING TUBE PLACEMENT, THE DEPTH MARKINGS ALLEGEDLY DISAPPEARED ON THE TUBE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10770719 ↗
• MalfunctionOct 26, 2020Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT APPROXIMATELY ONE DAY POST FEEDING TUBE PLACEMENT, THE LINEAR EXTERNAL BOLSTER ALLEGEDLY DAMAGED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10734370 ↗
• MalfunctionApr 8, 2020Fluid/Blood Leak; Nonstandard Device; Fitting Problem; Fluid/Blood Leak; Nonstandard Device; Fitting Problem

  IT WAS REPORTED THAT SOME TIME POST GASTROSTOMY FEEDING TUBE PLACEMENT, THE CAP OF THE FEEDING TUBE ADAPTER WAS ALLEGEDLY UNABLE TO CLOSE PROPERLY DUE TO FINS REMAINED IN THE CAP CAUSED AN ALLEGED LEAK. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9941125 ↗
• MalfunctionFeb 14, 2020Component Missing; Component Missing

  IT WAS REPORTED THAT UPON UNPACKING THE FEEDING DEVICE PACKAGE, THE GUIDEWIRE WAS ALLEGEDLY FOUND MISSING IN THE PACKAGE PRIOR TO USE ON PATIENT. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 9712144 ↗
• MalfunctionDec 2, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT THE DEPTH MARKINGS ALLEGEDLY WERE NOT PRINTED ON THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9398259 ↗
• MalfunctionJul 17, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT SUMMARIZES TWO MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 006035, FEEDING DEVICE ALLEGEDLY EXPERIENCED A FLUID LEAK. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. THE TWO MALFUNCTIONS INVOLVED PATIENTS WITH NO REPORTED CONSEQUENCE. THE PATIENTS¿ AGE, WEIGHT, AND SEX WERE NOT REPORTED FOR EITHER MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8798941 ↗
• MalfunctionApr 19, 2019Crack; Defective Component; Crack; Defective Component

  THIS REPORT SUMMARIZES ONE(1) MALFUNCTION EVENT. A REVIEW OF THE EVENTS INDICATED THAT MODEL 006035 FEEDING DEVICE ALLEGEDLY EXPERIENCED A CRACK. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THIS EVENT INVOLVED ONE MALE PATIENT, AGE AND WEIGHT WERE NOT PROVIDED. PATIENT HAD NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8533417 ↗
• MalfunctionDec 27, 2018Defective Component; Defective Component

  IT WAS REPORTED THAT AFTER THE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE WAS PLACED, THE TUBE WAS FOUND DAMAGED. IT WAS FURTHER REPORTED THAT THE TUBE WAS REPAIRED AND REMAINS IN THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8200595 ↗
• MalfunctionDec 27, 2018Break; Defective Component; Break; Defective Component

  IT WAS REPORTED THAT AFTER THE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE WAS PLACED, THE TUBE WAS FOUND DAMAGED. IT WAS FURTHER REPORTED THAT THE TUBE WAS REPAIRED AND REMAINS IN THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8199991 ↗
• MalfunctionOct 23, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT NUTRITION LEAKAGE OCCURRED FROM THE MIDDLE OF THE CATHETER AFTER THE CONSTRUCTED GASTROSTOMY. THE DAMAGED PART OF CATHETER WAS CUT OFF. THE REMAINING PIECE OF THE CATHETER IS CURRENTLY IN USE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7997492 ↗
• MalfunctionMay 9, 2018Defective Component; Defective Component

  IT WAS REPORTED THAT THE DEPTH MARKS ON THE CATHETER SHAFT HAD ALLEGEDLY DISAPPEARED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7500678 ↗
• MalfunctionMar 26, 2018Detachment Of Device Component

  IT WAS REPORTED THAT THE INTERNAL BUMPER THAT IS ATTACHED TO THE CATHETER MOVED FROM THE PATIENT'S STOMACH TO THE OUTSIDE OF THE STOMACH WALL. OBSERVING THE PATIENT'S SKIN SWELLING, THE CATHETER AND INTERNAL BUMPER WERE REMOVED FROM THE PATIENT. THE INTERNAL BUMPER DID NOT MIGRATE INSIDE THE STOMACH. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7370191 ↗
• MalfunctionMar 20, 2018Fluid/Blood Leak; Hole In Material

  IT WAS REPORTED THAT A HOLE IN THE CATHETER WAS FOUND ON THE OUTSIDE OF THE PATIENT'S BODY AND LEAKED TPN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7354690 ↗