Ponsky PEG Safety System 003029Recalls & reported problems
Bard Access Systems, Inc. · Ponsky PEG Safety System · Class 2 · Implant
All models of Ponsky PEG Safety System (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741086854), received between Jul 25, 2018 and Jun 5, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT SOMETIME POST FEEDING DEVICE PLACEMENT, THE PATIENT ALLEGEDLY EXPERIENCED INFECTION AT THE STOMA SITE. HOWEVER, THERE IS NO INFORMATION REGARDING ADDITIONAL INTERVENTION OR MEDICATION PROVIDED TO TREAT INFECTION. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17057970 ↗MalfunctionJul 25, 2018Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE PATIENTS FEEDING TUBE HAS AN ALLEGED BREAK. THERE IS NOT REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7720317 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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