PillCam FGS-0499Recalls & reported problems
Given Imaging, Inc. · SB 3-EX capsule, 10-pack · Class 2
All models of PillCam (22)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290101364375), received between Apr 3, 2023 and Sep 2, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Entrapment of Device” (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.
Reports received per month
Most reported problems
Device problems
- Entrapment of Device1
- Human-Device Interface Problem1
Patient problems
- Choking1
- Discomfort1
- Foreign Body In Patient1
- Inflammation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 2, 2025Human-Device Interface Problem; Human-Device Interface Problem
IT WAS REPORTED THAT A PATIENT COULD NOT SWALLOW THE CAPSULE AFTER TWO ATTEMPTS. THE PATIENT EXPERIENCED COUGHING, GAGGING AND SOME CHEST DISCOMFORT. THE PATIENT GAGGED AND THREW UP THE CAPSULE.
Patient problems: Choking; Discomfort
MAUDE report 22937172 ↗InjuryApr 3, 2023Entrapment of Device; Entrapment of Device
ACCORDING TO THE REPORTER, THE CAPSULE HAS BEEN IN THE PATIENT STOMACH FOR 6 WEEKS. NOTES FROM THE MEDICAL ADVISEMENT TEAM, NEGATIVE EGD AND COLON. SMALL BOWEL IMAGING SHOWED CHRONIC ENTERITIS AND WITH SUSPECTED CROHNS DECEASE. THE REPORT DID NOT SHOW ANY MUCOSAL EVIDENCE OF CROHN'S IN THE CAPSULE AND IT DID NOT PASS INTO THE CECUM ON THE VIDEO. A FOLLOW UP X-RAY SHOWED THE RETAINED CAPSULE IN WHAT WAS INITIALLY READ AS THE DESCENDING COLON. CT SCAN ON FOLLOW UP SHOWED LOCATION OF THE CAPSULE TO BE IN THE SMALL INTESTINE. PATIENT INITIAL SYMPTOMS WERE IMPROVING ON "BUDESONIDE", WHICH WAS STARTED 4 WEEKS AGO FOR CAPSULE INFLAMMATION AND HAD NO SIGNS OF OBSTRUCTION. PATIENT WAS DOING BETTER AND CLINICALLY NOT OBSTRUCTED. THE CAPSULE HAS NOT PASSED. PATIENT WAS FOLLOWED CLOSELY WITH SERIAL EXAMS AND IMAGING.
Patient problems: Foreign Body In Patient; Inflammation
MAUDE report 16665743 ↗
Other SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE devices
- CapsoCam Plus SV-3Capsovision, Inc. · System, Imaging, Gastrointestinal, Wireless, Capsule1 recall0 reports
- AdvanCE 00711144US Endoscopy · SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE40 reports
- PillCam FGS-0501Given Imaging, Inc. · SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE27 reports
- PillCam FGS-0391Given Imaging, Inc. · SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE2 deaths17 reports
- Pillcam FGS-0109Given Imaging, Inc. · SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE13 reports
- PillCam FGS-0400Given Imaging, Inc. · SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE11 reports
- Pillcam FGS-0347Given Imaging, Inc. · SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE1 death10 reports
- AdvanCE 00711144US Endoscopy · SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE10 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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