Ponsky Deluxe PEG Kit 000792Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741081132), received between Feb 17, 2017 and Mar 8, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 8, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING FEEDING DEVICE PLACEMENT PROCEDURE, THE DEVICE GUIDE WIRE ALLEGEDLY FRAYED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11431395 ↗
• MalfunctionSep 25, 2020Fracture; Failure to Advance; Material Split, Cut or Torn; Fracture; Failure to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING THE FEEDING TUBE PLACEMENT, THE DEVICE ALLEGEDLY UNABLE TO ADVANCE. IT WAS FURTHER REPORTED THAT THE DEVICE RIPS, SHEARS AND NOT LONG ENOUGH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10585368 ↗
• MalfunctionDec 12, 2018Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT THE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE WAS PLACED ALLEGEDLY AFTER THE EXPIRATION DATE OF THE PRODUCT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8157887 ↗
• MalfunctionFeb 17, 2017Migration or Expulsion of Device

  ON 1/27/17 - PER MEDWATCH FORM, FACILITY REPORTED THAT THE PEG MIGRATED OUT OF ITS INTERNAL POSITION ON DAY 5, POST PLACEMENT. THE PLACEMENT WAS CONFIRMED VISUALLY USING A SCOPE TO ENSURE THE GASTRIC BUMPER WAS IN PLACE, FOLLOWING THE APPLICATION OF THE EXTERNAL BUMPER. THE TUBE WAS WELL ANCHORED EXTERNALLY, THE EXTERNAL PLACEMENT WAS NOT MOBILE. PATIENT WAS RECEIVING PLASMAPHERESIS AND HAD FLUID WEIGHT GAIN DURING THIS TIME. THE NURSE DID NOT REPORT ANY TUGGING OR PULLING ON THE LINE DURING CARE. TUBE FEEDS WERE NOT STARTED UNTIL DAY 3. PATIENTS UPPER EXTREMITIES ARE VERY LIMITED DUE TO TRANSEVERSE MYELITIS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Weight Changes

  MAUDE report 6341050 ↗