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ManoScan 2192Recalls & reported problems

Given Imaging, Inc. · AR Catheter, Regular · Class 2

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 04260167482477), received between May 9, 2018 and May 9, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (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

  • Difficult to Remove1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionMay 9, 2018Difficult to Remove; Difficult to Remove

    ACCORDING TO THE REPORTER, THE BALLOON WAS STUCK INSIDE THE PATIENT'S BODY. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND OUTCOME.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7498761 ↗

Other SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) devices

All SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.