PillCam FGS-0498Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290101364368), received between Jul 14, 2020 and Sep 17, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Entrapment of Device” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Entrapment of Device

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50805764 ↗
• MalfunctionJul 14, 2020Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, THE PATIENT HAD A RETAINED CAPSULE. THE PATIENT UNDERWENT THE ENDOSCOPY AFTER A NEGATIVE COLONOSCOPY FOR HEME POSITIVE STOOL TESTING AND THE CAPSULE WAS BELIEVED TO BE RETAINED IN THE DISTAL JEJUNUM AT THE SITE OF A PROBABLE NSAIDS RELATED ULCERATED STRUCTURE. AFTER FAILING TO RETRIEVE THE CAPSULE WITH ENTEROSCOPY, THE PHYSICIAN WAS PLANNING ON DOUBLE BALLOON ENTEROSCOPY AND POSSIBLE SURGICAL INTERVENTION. THE PATIENT HAD NO OBSTRUCTIVE SYMPTOMS. THERE WAS REPORTED PATIENT OUTCOME AND NO USER HARM.

  Patient problems: No Information

  MAUDE report 10270756 ↗