Ponsky PEG Safety System 003027Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741081156), received between Aug 10, 2020 and Aug 10, 2020 — classified as 1 malfunction.
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
Device problems
- Break1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 10, 2020Break; Break
IT WAS REPORTED SOME TIME POST PEG TUBE PLACEMENT, THE DEVICE ALLEGEDLY BROKE. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10383600 ↗
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- Kangaroo 8884711253Cardinal Health, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)152 reports
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- NutraGlide Nasal Feeding Tube ENFT-05090-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
- Kangaroo 8884711253ECardinal Health, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)100 reports
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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