Ponsky Deluxe PEG Kit 000627Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741081071), received between Apr 18, 2019 and Jul 22, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2019Deflation Problem; Deflation Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 000627 TUBES, GASTROINTESTINAL (AND ACCESSORIES) ALLEGEDLY DID NOT PRESENT ADEQUATE DURABILITY AND THERE WAS A NEED TO EXCHANGE AN EXTERNAL PART. THERE WAS NO REPORTED PATIENT INJURY. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8813846 ↗
• MalfunctionApr 18, 2019Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT. A REVIEW OF THE EVENTS INDICATED THAT MODEL 000627 FEEDING DEVICE ALLEGEDLY EXPERIENCED A BREAK AND FLUID LEAK. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THE DEVICE WAS USED IN THE PATIENT. AGE, WEIGHT, GENDER AND STATUS OF THE PATIENT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8528287 ↗