PillCam FGS-0668Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07290110360825), received between Sep 1, 2020 and Apr 26, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Entrapment of Device” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 26, 2022Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, THE PATENCY CAPSULE TOOK LONGER THAN NORMAL TO DISSOLVE OUT THE PATIENT'S BODY. IT PASSES OUT THE PATIENT'S BODY BETWEEN (B)(6) 2022 OR (B)(6) 2022 PER X-RAY RESULTS. THE CUSTOMER STATED THAT THE PATIENT WAS HOSPITALIZED ON (B)(6) 2022 FOR ABDOMINAL PAIN AND DISCHARGED ON (B)(6) 2022. THE ABDOMINAL PAIN RESOLVED AFTER THE PATENCY CAPSULE PASSED OUT OF THE PATIENT'S BODY.

  Patient problems: Abdominal Pain

  MAUDE report 14214792 ↗
• InjurySep 29, 2021Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, THE PATENCY CAPSULE CAUSED AN OBSTRUCTION AND THE PATIENT WAS ADMITTED AND RECEIVED A CT OF THE ABDOMEN/PELVIS. THE PATIENT WAS FINE AND DID NOT HAVE TO HAVE ANY SURGERIES. HOWEVER AFTER 72 HOURS, THE CAPSULE CAME OUT INTACT AND DID NOT DISSOLVE. THE PATIENT WAS NO LONGER OBSTRUCTED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 12548161 ↗
• InjurySep 1, 2020Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, THE PATENCY CAPSULE WAS STILL PRESENT INSIDE THE PATIENT'S CAVITY. AN IMAGING WAS PERFORMED TWICE AND THEY CONFIRMED THE CAPSULE LOCATION. PATIENT WAS ALSO COMPLAINING OF ABDOMINAL PAIN. PATIENT HAD A DIAGNOSIS OF CROHN'S DISEASE. THE MEDICAL SAFETY TEAM SAW FROM THE IMAGING A SMALL METALLIC RFID TAG IN THE LOWER RIGHT QUADRANT AREA AND NO EVIDENCE OF BOWEL OBSTRUCTION. THE CAPSULE ALREADY PASSED ON ITS OWN AFTER 7 DAYS.

  Patient problems: Abdominal Pain; Radiation Exposure, Unintended

  MAUDE report 10480422 ↗