PillCam FGS-0200Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07290101361145), received between Aug 25, 2017 and Aug 25, 2017 — 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

Recent adverse event reports

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

• InjuryAug 25, 2017Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, A PATIENT UNDERWENT A PROCEDURE IN 2011, PRIOR TO WHICH THE PATIENT HAD A SUCCESSFUL PATENCY PROCEDURE, AND HAS HAD THE CAPSULE RETAINED WITHIN HIM/HER SINCE THEN. THE PATIENT HAD A BARIUM SWALLOW AND SMALL BOWEL FOLLOW THROUGH (SBFT) FOR FOLLOW-UP CARE FOR CROHN'S DISEASE. THERE WAS NO EXACERBATION OF DISEASE THAT PROMPTED THIS RECENT EXAMINATION. THE EXAMINATION DEMONSTRATED THAT THE CAPSULE REMAINS RETAINED WITH A SLIGHTLY DILATED LOOP OF THE ILEUM. THE REPORTER STATES THAT THE CAPSULE APPEARED TO HAVE SEPARATED INTO TWO COMPONENTS.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6820004 ↗