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Ponsky PEG Kit 010060Recalls & reported problems

Bard Access Systems, Inc. · Ponsky PEG Kit · Class 2 · Implant

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports
6
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741081200), received between Dec 12, 2018 and May 20, 2021 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break2
  • Migration2
  • Device Contaminated During Manufacture or Shipping1
  • Device Contamination with Chemical or Other Material1
  • Fluid/Blood Leak1
  • Fracture1

Patient problems

  • No Clinical Signs, Symptoms or Conditions3
  • Abscess1
  • Inflammation1
  • No Consequences Or Impact To Patient1
  • No Patient Involvement1
  • Pain1

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 20, 2021Migration; Migration

    IT WAS REPORTED THAT DURING A FEEDING TUBE PLACEMENT PROCEDURE, THE TUBE ALLEGEDLY MIGRATED WHILE REMOVING THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11854813 ↗
  • MalfunctionMay 20, 2021Migration; Migration

    IT WAS REPORTED THAT DURING A FEEDING TUBE PLACEMENT PROCEDURE, THE TUBE ALLEGEDLY MIGRATED WHILE REMOVING THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11854812 ↗
  • MalfunctionNov 16, 2020Break; Fracture; Break; Fracture

    IT WAS REPORTED ONE DAY POST FEEDING DEVICES PLACEMENT, THE TUBE ALLEGEDLY CRACKED. NO PROBLEMS WERE FOUND WITH THE PRODUCT AT THE TIME OF THE IMPLANTATION PROCEDURE. AND AFTER INSERTION, A CRACK IN THE TUBE WAS FOUND IN THE STAGE FOR INJECTING FLUID FOOD INTO THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10842279 ↗
  • MalfunctionDec 11, 2019Device Contamination with Chemical or Other Material; Device Contaminated During Manufacture or Shipping; Device Contamination with Chemical or Other Material; Device Contaminated During Manufacture or Shipping

    IT WAS REPORTED THAT PRIOR TO OPEN THE PACKAGE OF THE GASTROSTOMY FEEDING TUBE, AN INSECT WAS ALLEGEDLY FOUND IN THE KIT. REPORTEDLY, ANOTHER KIT WAS USED TO PERFORM THE PROCEDURE. THERE WAS NO PATIENT CONTACT.

    Patient problems: No Patient Involvement

    MAUDE report 9451421 ↗
  • InjurySep 24, 2019Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED THAT APPROXIMATELY ONE WEEK POST GASTROSTOMY FEEDING TUBE PLACEMENT, THE DEVICE WAS ALLEGEDLY LEAKING. IT WAS FURTHER REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO ALLEGED PAIN, SEPSIS, AND WALL ABSCESS AROUND THE STOMA. REPORTEDLY, TREATMENT FOR THE INFECTION WAS PROVIDED AND THE DEVICE WAS REPLACED. THE PATIENT STATUS IS UNKNOWN.

    Patient problems: Abscess; Inflammation; Pain

    MAUDE report 9112931 ↗
  • MalfunctionDec 12, 2018Break; Break

    IT WAS REPORTED THE FEEDING CATHETER ALLEGEDLY SLIT CAUSING THE ADAPTER (CAP) TO DISLODGE FROM THE FEEDING DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8157919 ↗

Other TUBES, GASTROINTESTINAL (AND ACCESSORIES) devices

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Sources and updates

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