PillCam FGS-0519Recalls & reported problems
Given Imaging, Inc. · COLON 2 capsule, 10-pack · Class 2
All models of PillCam (22)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07290101364801), received between Nov 23, 2021 and Nov 23, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Human-Device Interface Problem” (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
- Human-Device Interface Problem1
Patient problems
- Choking1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 23, 2021Human-Device Interface Problem; Human-Device Interface Problem
ACCORDING TO THE REPORTER, THE PATIENT CHOKED WHILE SWALLOWING THE CAPSULE. IT BECAME DISLODGE IN THE PATIENT'S THROAT. HEIMLICH MANEUVER WAS PERFORMED TO REMOVE THE CAPSULE. THE PATIENT'S AIRWAY WAS NOT OBSTRUCTED WHEN ATTEMPTING TO SWALLOW THE CAPSULE AND OTHER ATTEMPTS WERE MADE.
Patient problems: Choking
MAUDE report 12865264 ↗
Other Colon capsule imaging system devices
- PillCam FGS-0517Given Imaging, Inc. · Colon capsule imaging system7 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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