PillCam FGS-0667Recalls & reported problems
Given Imaging, Inc. · PillCam™ patency capsule, 1-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 07290110360818), received between Mar 6, 2023 and Mar 6, 2023 — classified as 1 injury.
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.
Most reported problems
Device problems
- Entrapment of Device1
Patient problems
- Obstruction/Occlusion1
- Unintended Radiation Exposure1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 6, 2023Entrapment of Device; Entrapment of Device
ACCORDING TO THE REPORTER, THE CAPSULE WAS INGESTED AND AFTER A WEEK THE PATIENT DEVELOPED OBSTRUCTIVE SYMPTOMS. PATIENT HAD AN X-RAY AND SHOWED THE PATENCY CAPSULE WAS STILL IN THE SMALL BOWEL AND INTACT. PATIENT WAS ADMITTED TO THE HOSPITAL AND HAD SURGERY LAPAROSCOPY MOVED TO LAPAROTOMY FOR LYSIS ADHESION, SMALL BOWEL RESECTION FOR OBSTRUCTION AND APPENDIX REMOVAL. PATIENT WAS CURRENTLY IN THE HOSPITAL FOR POST SURGERY.
Patient problems: Obstruction/Occlusion; Unintended Radiation Exposure
MAUDE report 16491534 ↗
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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