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Kangaroo 8884752067Recalls & reported problems

Cardinal Health, Inc. · Single Pass PEG Kit · Class 2 · Implant

Data updated Oct 13, 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 10884521070059), received between Apr 11, 2018 and Apr 11, 2018 — classified as 1 malfunction.

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

Most reported problems

Device problems

  • Detachment Of Device Component1

Patient problems

  • No Information1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 11, 2018Detachment Of Device Component; Detachment Of Device Component

    THE CUSTOMER STATES THAT WHILE PREPPING THE PEG, THE GUIDE WIRE RUPTURED AND DETACHED FROM THE TUBE CAUSING IT TO PARTIALLY PERFORATE THE GASTRIC WALL AND WAS IN THE STOMACH CAVITY. THEY NEEDED TO RESTART WITH A NEW TUBE AND DUE TO THE IMMINENT RISK OF THE BLEEDING AND PNEUMO-PERITONEUM, THE PATIENT¿S HOSPITAL STAY WAS EXTENDED. THERE WAS NO PATIENT INJURY AS A RESULT OF THE EVENT.

    Patient problems: No Information

    MAUDE report 7421618 ↗

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Sources and updates

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