PillCam FGS-0500Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07290101364382), received between Jul 7, 2021 and Apr 27, 2026 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Human-Device Interface Problem” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2026Human-Device Interface Problem

  IT WAS REPORTED THAT THE PATIENT COULD NOT SWALLOW THE CAPSULE AND THE RECORDER WOULD NOT RESPOND WHEN CHECKING IN THE NEXT PATIENT. THERE WAS NO PATIENT AND USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24999794 ↗
• InjuryApr 3, 2026Failure to Transmit Record

  IT WAS REPORTED THAT WHEN THE DOCTOR DEPLOYED THE CAPSULE, IT STOPPED WORKING. IT FAILED TO STAY ON ONCE THE PATIENT INGESTED THE CAPSULE. THE DOCTOR REMOVED THE CAPSULE FROM THE PATIENT'S BODY USING A BASKET AND RESTARTED THE STUDY WITH A NEW CAPSULE.

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

  MAUDE report 24776072 ↗
• MalfunctionJan 13, 2026Human-Device Interface Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A CAPSULE GETTING STUCK IN THE THROAT AND CHOKED. THE CUSTOMER STILL USED THE CAPSULE TO CONTINUE THE STUDY AND WAS ABLE TO COMPLETE SUCCESSFULLY AFTER THE SECOND ATTEMPT. THERE WAS NO PATIENT OR USER HARM.

  Patient problems: Choking

  MAUDE report 24052837 ↗
• MalfunctionJan 13, 2026Human-Device Interface Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A CAPSULE GETTING STUCK IN THE THROAT AND CHOKED. THE CUSTOMER STILL USED THE CAPSULE TO CONTINUE THE STUDY AND WAS ABLE TO COMPLETE SUCCESSFULLY AFTER THE SECOND ATTEMPT. THERE WAS NO PATIENT OR USER HARM.

  Patient problems: Choking

  MAUDE report 24052759 ↗
• InjuryJun 26, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE CAPSULE WAS STILL IN GASTROINTESTINAL TRACT SINCE (B)(6) 2025 EVEN AFTER SEVERAL BOWEL CLEAN OUTS. AN X-RAYS AND CT SCAN HAVE CONFIRMED RETENTION.

  Patient problems: Foreign Body In Patient

  MAUDE report 22338282 ↗
• InjurySep 2, 2022Failure to Transmit Record; Failure to Transmit Record

  ACCORDING TO THE REPORTER, THE CAPSULE FAILED TO SYNC WITH THE RECORDER. THEY TRIED ANOTHER SENSOR BELT AND RECORDER BUT THE CAPSULE WOULD NOT PAIR. THE FIRST RECORDER SHUT DOWN IN THE MIDDLE OF THE STUDY. THE PATIENT HAD SOME DISCOMFORT IN LOW ABDOMEN. X-RAY WAS PERFORMED 4 HOURS AFTER INGESTION TO SEE IF THE CAPSULE WAS STUCK, AND THE CAPSULE WAS FOUND IN THE CECUM. THE PATIENT SWALLOWED THE CAPSULE AT 8:10 AM ON (B)(6)AND DEVICE FLASHED A GREEN ENVELOPE, A BEEP THEN SHUT OFF. IT WAS RETURNED TO OFFICE AND DEVICE WAS OFF. THE DEVICE WAS PLACED ON THE CRADLE BUT UNABLE TO READ ANYTHING. THE PATIENT EXPERIENCED SIGNIFICANT LOWER RIGHT ABDOMINAL PAIN WHILE HERE SO WAS SENT TO ER FOR X-RAY BUT SHE LEFT BEFORE SEEING A PHYSICIAN. PATIENT STILL HAVING SLIGHT PAIN. THE CAPSULE DID PAIR WITH THE RECORDER PRIOR TO INGESTION.

  Patient problems: Abdominal Pain; Discomfort; Unintended Radiation Exposure

  MAUDE report 15352465 ↗
• MalfunctionAug 24, 2021Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, THE PATIENT HAD ISSUE SWALLOWING THE CAPSULE. AFTER A COUPLE OF TRIES, THE PATIENT WAS UNABLE TO SWALLOW THE CAPSULE AND THE STUDY WAS CANCELLED. THERE WAS NO PATIENT AND USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12363205 ↗
• MalfunctionJul 7, 2021Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, THE PATIENT TRIED TO SWALLOW THE CAPSULE TWICE AND WAS UNABLE TO. THE CAPSULE WAS LEFT BLINKING FOR ALMOST 2 HOURS. THERE WAS NO PATIENT AND USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12129101 ↗