PillCam FGS-0400Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07290101362227), received between Nov 13, 2018 and Dec 22, 2025 — classified as 8 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAPSULE PROCEDURE WAS PERFORMED DUE TO REPORTED IRON DEFICIENCY ANEMIA. THE PATIENT ADVISED THAT THEY HAVE PASSED THE CAPSULE ON (B)(6) 2025, IN THE MORNING AND DID NOT NOTICE ANY BLOOD, MUCOUS, OR ANY ABNORMALITY WHEN IT CAME AWAY. THE PATIENT STARTED FEELING UNWELL ON (B)(6) 2025 AND ON (B)(6) 2025, THE PATIENT WAS IN EXCRUCIATING PAIN, BY THEN, THEY ATTENDED "ACCIDENT AND EMERGENCY". THE NEXT MORNING, ON (B)(6) 2025, COMPUTED TOMOGRAPHY SCAN WAS DONE WHICH CONFIRMED A HOLLOW VISCUS PERFORATION WITHIN THE PROXIMAL DUODENUM, TO WHICH SUGGESTED A SURGERY. ON THE SAME DAY, A SURGERY OF OPEN ABDOMINAL OMENTAL PATCH REPAIR WAS PERFORMED AND UNDERWENT GENERAL ANESTHESIA FOR THE DIAGNOSTIC LAPAROSCOPY, HAD TAKEN DOWN ADHESIONS, LAPAROTOMY, AND WASHED OUT PERFORATED DUODENAL ULCER. NO ENDOSCOPY WAS PERFORMED AT THE TIME OF ADMISSION UNTIL (B)(6) 2025. DURING ADMISSION, THE PATIENT WAS GIVEN ENOXAPARIN FOR DVT (DEEP VEIN THROMBOSIS) PROPHYLAXIS AND ANALGESIA FOR PAIN RELIEF. THE COMPUTED TOMOGRAPHY SCAN MADE REFERENCE TO A DUODENAL ULCER AS PART OF THE DIFFERENTIAL AND IT DID LOOK TO BE THE CASE BASED ON HOW THE CAPSULE VIDEO LOOKED. THE PATIENT HAD A FOLLOW-UP ON (

  Patient problems: Pain

  MAUDE report 23863072 ↗
• MalfunctionAug 20, 2025Failure to Transmit Record; Human-Device Interface Problem; Failure to Transmit Record; Human-Device Interface Problem

  IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO SWALLOW THE CAPSULE, AND SO THE PHYSICIAN PROCEEDED TO AN ENDOSCOPIC CAPSULE PLACEMENT SOON AFTER. HOWEVER, WHILST PREPARING THE ROOM AND THE PATIENT, THE CAPSULE AND THE RECORDER LOST CONNECTION TO EACH OTHER DESPITE THE RECORDER AND BELT STILL BEING ATTACHED TO THE PATIENT. THE CAPSULE, RECORDER AND BELT WERE CLOSE TO THE PATIENT THROUGHOUT. THE CAPSULE WAS FLASHING BUT IN PREPARATION AND HAD TO CLOSE THE COVER FOR THE INFECTION CONTROL PURPOSES. AN EXCLAMATION POINT ALERT ON THE SCREEN APPEARED ON THE RECORDER AND THE CAPSULE WOULD NOT CONNECT TO THE RECORDER AT ALL. THE CUSTOMER HAD TO USE DIFFERENT DEVICES ALTOGETHER. THERE WAS NO PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22849363 ↗
• InjuryMar 11, 2025Failure to Transmit Record; Failure to Transmit Record

  IT WAS REPORTED THAT THE CAPSULE DID NOT WORK WITHIN ONE HOUR AFTER INGESTION. THE HEALTHCARE PROFESSIONAL TRIED REPLACING THE RECORDER AND THE SENSOR BELT TO CHECK WHAT WAS CAUSING THE PROBLEM. HOWEVER, THE CAUSE WAS NOT RECOGNIZED. SINCE IT WAS A PEDIATRIC PATIENT, THE TEST WAS STARTED FROM THE BEGINNING WITH ANOTHER CAPSULE AND THE TEST WAS COMPLETED NORMALLY. THE PATIENT HAD AN X-RAY WHICH SHOWED BOTH TWO CAPSULES INSIDE THE BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21577151 ↗
• InjuryOct 22, 2024Material Fragmentation; Optical Distortion; Material Fragmentation; Optical Distortion

  ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT THE STUDY DUE TO IRON DEFICIENCY ANEMIA AND HAD NO ADVERSE EVENTS. THE VIDEO SHOWED THAT THE CAPSULE ENTERED THE ESOPHAGUS AND STOMACH, AND SOMETIME AFTER SEVEN MINUTES, AN IRREGULAR WHITE VERTICAL LINE APPEARED IN THE VIDEO, TRANSVERSING THE IMAGE COMPLETELY. THEN, QUICKLY, THE VIDEO IMAGES BECAME CHAOTIC, BUT THE CAPSULE CONTINUED TO TRANSMIT OVER 10 HOURS OF VIDEO, WHICH MADE THE CUSTOMER ALLEGE THE CAPSULE BROKE INSIDE THE BODY. UPON REVIEW OF THE VIDEO BY THE ENGINEERING TEAM, IT WAS DETERMINED TO BE AN IMAGER FAILURE OF THE CAPSULE AND NOT A BROKEN CAPSULE. THE PATIENT HAD AN X-RAY, AND NO CAPSULE OR CAPSULE PARTS WERE VISIBLE. THE PATIENT DID UNDERGO THE NEW CAPSULE STUDY. THE PATIENT DID NOT HAVE ANY ADVERSE SYMPTOMS.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 20504712 ↗
• InjuryDec 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE SOURCE PERFORMED (B)(6) 2023;, A CASE STUDY PRESENTED AN 82-YEAR-OLD MALE PATIENT WHO UNDERWENT VIDEO CAPSULE ENDOSCOPY USING THE PILLCAM SB 3 SYSTEM TO EXAMINE SMALL BOWEL BLEEDING. IMMEDIATELY AFTER SWALLOWING, THE PATIENT COMPLAINED OF CHEST DISCOMFORT (WITHOUT RESPIRATORY DISTRESS). THE PATIENT EXPERIENCED A COUGH AND A FOREIGN BODY SENSATION IN THE THORAX. REAL-TIME VIDEO CAPSULE ENDOSCOPY REVEALED A BIFURCATED LUMEN WITH RING-SHAPED CARTILAGE. FLEXIBLE BRONCHOSCOPY WAS PERFORMED AND CONFIRMED THE PRESENCE OF THE CAPSULE ENDOSCOPE IMPACTED WITHIN THE RIGHT MAIN BRONCHUS. THE CAPSULE WAS REMOVED USING A SNARE.

  Patient problems: Aspiration/Inhalation; Chest Pain; Cough

  MAUDE report 18341345 ↗
• InjuryNov 18, 2021Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, THEY HAD A PATIENT THAT PERFORMED A VIDEO CAPSULE ON (B)(6) THIS YEAR AND THE CAPSULE WAS RETAINED. THE PATIENT WAS SUSPECTED TO HAVE CROHN'S DISEASE. THE PATIENT WAS UNDER SURVEILLANCE WITHOUT ANY COMPLICATION OF THE RETAINED CAPSULE. AFTER A FEW MONTHS, THEY PERFORMED CT SCAN TO CHECK IF A CAPSULE WAS STILL INSIDE THE PATIENT AND THE PHYSICIAN STATED THAT ON THE CT SCAN IMAGES, THEY SAW 3 METAL PARTS BUT NOT THE VISUALIZATION OF THE CAPSULE. THE PATIENT WAS STILL UNDER SURVEILLANCE AND LAST MONTH THEY DID ANOTHER SCREENING TEST AND SAW ON THE CT SCAN THAT ONLY ONE METAL PART INSTEAD OF 3 WAS VISIBLE AS COMPARED TO WHAT WAS MENTIONED BEFORE. THE PATIENT WAS FEELING GOOD AND WAS NOT HOSPITALIZED. NO CAPSULE PARTS HAVE BEEN RECOVERED AND THE PATIENT HAD NO SYMPTOMS.

  Patient problems: Foreign Body In Patient

  MAUDE report 12834931 ↗
• InjuryJul 6, 2021Signal Artifact/Noise; Entrapment of Device; Signal Artifact/Noise; Entrapment of Device

  ACCORDING TO THE REPORTER, THEY HAD STUDY THAT SHOWED GAPS. BOTH THE RECORDER AND SENSOR BELT WORKED CORRECTLY DURING THE PREVIOUS PROCEDURE. SUBSEQUENTLY, THE PATIENT HAD BOWEL OBSTRUCTION AND CT/XR SCANS SHOWED DISINTEGRATED CAPSULE. THEY TRIED TO DO A WASHOUT WITH PICOLAX, WITH NO SUCCESS. THEY STARTED ON STELARA TO MINIMIZE THE INFLAMMATION IN THE AREA AND WILL TRY WITH THE DBE TO REMOVE THE CAPSULE.

  Patient problems: Obstruction/Occlusion; Unintended Radiation Exposure

  MAUDE report 12123575 ↗
• InjuryJul 31, 2020Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT A PROCEDURE FOR A SMALL BOWEL BLEED USING A VIDEO CAPSULE. THE FOLLOWING DAY, IT WAS NOTED THAT THE CAPSULE WAS IN THE PATIENT'S STOMACH. THE CAPSULE WAS RETAINED IN THE PATIENT'S STOMACH FOR 12 HOURS. THE CAPSULE WAS RETRIEVED BY ENDOSCOPY.

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 10352652 ↗
• InjuryMar 9, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, THE PATIENT NOTICED A GAP ON THE CAPSULE WHEN IT WAS EXCRETED. THE GAP WAS BETWEEN THE DOME AND THE CAPSULE BODY. THEY WILL CHECK WHETHER THE PARTS OF THE CAPSULE REMAINED IN THE BODY. AN EXTENDED HOSPITALIZATION WAS NECESSARY. THE PATIENT HAD MORE DIARRHEA AND WOULD NEED A STOMA. THEY WILL DECIDE ON AN OPERATION AND THEY WOULD LIKE TO KNOW IF THE ADVERSE EVENT WAS ASSOCIATED WITH THE CAPSULE.

  Patient problems: Death; Diarrhea; Injury

  MAUDE report 9805018 ↗
• MalfunctionJan 18, 2019Entrapment of Device; Poor Quality Image; Entrapment of Device; Poor Quality Image

  ACCORDING TO THE REPORTER, THE CAPSULE WAS STUCK IN THE STOMACH AND THE STUDY HAD POOR PICTURE QUALITY. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8262150 ↗
• MalfunctionNov 13, 2018Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, THE CAPSULE WAS BLOCKED IN THE PATIENT. THE CAPSULE WAS INGESTED IN ORDER TO EXPLORE ANEMIA, BUT WAS NOT ABLE TO EVACUATE BECAUSE OF THE STENOSIS OF HAIL. THERE WAS NO SURGICAL INTERVENTION FOR THE MOMENT TO RETRIEVE IT. THE PATIENT WAS PREPPED FOR THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: Stenosis

  MAUDE report 8065583 ↗