PillCam FGS-0391Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 07290101364085), received between May 22, 2018 and Oct 30, 2024 — classified as 2 deaths, 12 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (12 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2024Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, THE PATIENT HAD A CAPSULE RETENTION IN THE SMALL BOWEL. THERE WAS NO PATIENT OR USER HARM.

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

  MAUDE report 20567030 ↗
• InjuryJul 13, 2023Entrapment of Device; Material Fragmentation; Entrapment of Device; Material Fragmentation

  THE PATIENT REPORTED THAT THE SURGEONS FROM 3 HOSPITALS TRIED REMOVE THE CAPSULE FOR NINE AND HALF YEARS. THE PATIENT HAD MOST OF HER BOWEL REMOVED. THE CAPSULE WAS REMOVED AT THAT TIME. THE CAPSULE HAD BROKEN IN HALF AND WAS LYING IN THE BOWELS PELVIS AREA SINCE 2018 AS SURGEONS LAST SEEN THE CAPSULE. THE PATIENT REACHED OUT TO MEDTRONIC AND WERE SURPRISED WITH WHAT HAD HAPPENED. THE SURGEON OVER THE YEARS FAILED TO REPORT MEDTRONIC. MEDTRONIC DIRECTOR REACHED OUT THE PATIENT DISCUSSING THE CARE OVER AN YEAR AND WANTED THE EVENT DETAILS FROM THE PATIENT. WHEN CAPSULE WAS REMOVED, THE SURGEONS DID NOT SEND THE CAPSULE TO MEDTRONIC FOR ANALYSIS. SURGEONS PROVIDED A CAPSULE PICTURE TO THE PATIENT. THE PATIENT WAS UNAWARE OVER THE YEARS THAT THE CAPSULE WAS KILLING HER AND STARTED TO ULCERATE THROUGHOUT THE BOWEL.

  Patient problems: Bowel Perforation; Foreign Body In Patient; Ulcer

  MAUDE report 17319501 ↗
• InjuryJul 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, CAPSULE ENDOSCOPY WAS DONE AND THE NURSE CONFIRMED THAT THE CAPSULE ENTERED THE PATIENT COLON. NO SYMPTOMS WERE EXPERIENCED BY THE PATIENT DURING THE PROCEDURE BUT THE EXCRETION OF THE CAPSULE WAS NOT CONFIRMED SO AN X-RAY WAS ORDERED AND THE RESULT CONFIRMED THAT THE CAPSULE WAS EXCRETED. PATIENT THEN REQUIRED A MRI IN (B)(6) 2023, AND THE RADIOLOGIST STOPPED THE PROCEDURE BECAUSE A METAL WAS SEEN IN THE PANCREAS. IT WAS REPORTED IT WAS BECAUSE OF THE RESULT OF THE CAPSULE ENDOSCOPY PROCEDURE. HOWEVER, THE NURSE REPORTED THAT THE IMAGE ON THE RADIOLOGY IMAGING WAS A COIL THAT USED IN THE PANCREAS AND NOT THE CAPSULE. THE PATIENT HAS RECOVERED.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 17301950 ↗
• DeathJul 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, A PATIENT INGESTED A CAPSULE 8:00 IN THE MORNING OF (B)(6) 2022, WHO WAS UNDERGOING CAPSULE ENDOSCOPY FOR IRON DEFICIENT ANEMIA. THE PATIENT HAD A HISTORY OF ADENOCARCINOMA INCLUDED PRIOR GASTROSCOPY AND COLONOSCOPY FOR POLYPS. THE PATIENT WAS REPORTEDLY FINE POST INGESTION AT THE ENDOSCOPY UNIT. THE PATIENTS' HUSBAND RANG THE ENDOSCOPY UNIT EARLY AFTERNOON REPORTING THE PATIENT HAD SEVERE ABDOMINAL PAIN AND WAS NAUSEOUS. THEY WERE ADVISED TO RETURN TO ENDOSCOPY UNIT AS SOON AS POSSIBLE, HOWEVER, AMBULANCE SERVICE WAIT TIME WAS 2 HOURS. THEREFORE, THEY WERE ADVISED TO RETURN UNDER THEIR OWN TRANSPORT. PATIENT WAS DRIVEN BACK TO ENDOSCOPY UNIT AND WAS ASSESSED. THEN THEY WERE TRANSFERRED TO EMERGENCY DEPARTMENT WHERE A CT SCAN WAS REQUESTED. THE CT SCAN INDICATED CAPSULE WAS LOCATED IN THE PATIENTS' CECUM. THE PATIENT REPORTEDLY HAD VERY LOW BLOOD PRESSURE, AND WAS CLINICALLY UNWELL WITH SEPSIS. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT, HOWEVER, THE PATIENT PASSED AWAY SHORTLY AFTER ADMISSION. ALLEGEDLY INVESTIGATION INDICATED PATIENTS' CAUSE OF DEATH WAS ACUTE PANCREATITIS. THE HEALTH CARE TEAM MENTIONED THAT ACUTE PANCREATITIS AND RELATED FIND

  Patient problems: Abdominal Pain; Low Blood Pressure/ Hypotension; Nausea; Sepsis

  MAUDE report 14958574 ↗
• InjuryNov 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THEY USED THE DEVICE FOR A PATIENT WHO HAD A SUBCUTANEOUS MAGNET. THE DEVICE STUCK AT THE MAGNET AND DID NOT FALL INTO THE SMALL BOWEL. THE DEVICE WAS REMOVED MANUALLY WITH A GRASPER.

  Patient problems: Foreign Body In Patient

  MAUDE report 12866123 ↗
• InjuryOct 5, 2021Entrapment of Device; Unintended Application Program Shut Down; Entrapment of Device; Unintended Application Program Shut Down

  ACCORDING TO THE REPORTER, THEY HAD A SHORT STUDY. THE CUSTOMER CALLED STATING THAT THE PATIENT RETURNED FROM A CAPSULE STUDY AND ON INSPECTION OF THE VIEWER IT WAS STILL IN THE SMALL BOWEL. THE PATIENT WAS TOLD TO GO FOR A WALK AND CAME BACK HALF AN HOUR LATER. THE ORANGE LIGHT ON THE RECORDER WAS FLASHING BUT THERE WAS NO VIEW ON THE RECORDER. THE CUSTOMER THEN DISCONNECTED THE SENSOR AFTER THEY HAD THE ORANGE LIGHT AND NOTHING ON THE SCREEN. THE RECORDER WAS ONLY FLASHING ORANGE AND BLACK IMAGE WHEN THEY CHECKED THE LIVE VIEW, AFTER THE PATIENT WENT BACK TO THE HOSPITAL. TECHNICAL SUPPORT ASKED THE CUSTOMER TO CHECK WITH THE DOCTOR AFTER REVIEW TO CONFIRM IF THE CAPSULE HAD REACHED THE SMALL BOWEL. THE CUSTOMER CALLED BACK AND STATED THAT THE NOTES FROM THE DOCTOR CONFIRMED THAT THE CAPSULE HAD NOT REACHED THE COLON. WHEN THE DOCTOR WAS THAT THE END VIDEO WAS STILL IN SMALL BOWEL THE DOCTOR HAD THEM HAVE AN X-RAY DUE TO SUSPECTED CAPSULE RETAINMENT. HOWEVER IT WAS CONFIRMED THAT THE CAPSULE WAS PASSED NATURALLY BY THE PATIENT. THE RECORDER AND SENSOR BELT WORKED WITHOUT ISSUE PREVIOUSLY. THERE WAS NO PATIENT OR USER HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 12576389 ↗
• DeathJul 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT WAS HOSPITALIZED FOR DIGESTIVE BLEEDING OF OBSCURE ORIGIN WHICH WAS IN THE MIDDLE PART OF THE DIGESTIVE SYSTEM, SMALL INTESTINE. THE PATIENT SWALLOWED THE CAPSULE ON (B)(6) 2021. THE PATIENT HAD NO SWALLOWING DISORDERS AND WAS ABLE TO SWALLOW THE CAPSULE WITHOUT DIFFICULTY. 5 DAYS AFTER THE STUDY WAS CARRIED OUT, THE PATIENT DIED WITH THE CAPSULE IN THE BODY. THE STUDY YIELDED NO RESULTS. THE PATIENT HAD NO DELAYED GASTRIC EMPTYING ISSUES AND NO INTERVENTION WAS DONE TO REMOVE THE CAPSULE. WHEN VIEWING THE IMAGES, THE DOCTOR WAS ABLE TO VERIFY THAT THE CAPSULE WAS MORE THAN 8 HOURS IN THE ESOPHAGUS WHEN THE NORMAL THING WAS THAT IT PASSES IN 15 SECONDS. IT STAYED 3 HOURS IN THE STOMACH WHERE THE CAPSULE WAS DEACTIVATED DUE TO HAVING EXHAUSTED THE 11 HOURS OF BATTERY. THE STUDY WAS INCOMPLETE BECAUSE THE CAPSULE DID NOT REACH THE BLIND COLON DUE TO THE SLOWING DOWN OF THE PATIENT'S TRANSIT TIMES. THE PRODUCT SPECIALIST WAS ABLE TO SEE THE VIDEO AND OBSERVED THE SAME THING THAT THE DOCTOR INDICATED REGARDING THE TOTALLY ALTERED TRANSIT TIMES. THE CAPSULE PROGRESSED THROUGH THE MUCOSA OF THE DIGESTIVE SYSTEM, PROPELLED BY THE PERISTALTIC MOVEMENT

  Patient problems: Insufficient Information

  MAUDE report 12229094 ↗
• InjuryJul 13, 2021Entrapment of Device; Material Fragmentation; Entrapment of Device; Material Fragmentation

  ACCORDING TO THE REPORTER, ON (B)(6) 2021 A PATIENT WITH A HISTORY OF ABDOMINAL PAIN UNDERWENT THE DEVICE PROCEDURE. THERE WAS A SUCCESSFUL CAPSULE VIDEO CREATION WITH FINDING SHOWING ULCERATED STRICTURE AT THE DISTAL TERMINAL ILEUM. THE PATIENT REPORTED THAT THE CAPSULE WAS NOT PASSED UPON RETURN OF THE EQUIPMENT, AND A FOLLOW UP X-RAY WAS SCHEDULED. AN X-RAY ON (B)(6) 2021 SHOWED WHAT APPEARED TO BE A RETAINED CAPSULE AND WAS READ AS BEING IN THE COLON. ANOTHER FOLLOW-UP X-RAY WAS DONE ON (B)(6) 2021, SHOWING WHAT APPEARED TO BE A RETAINED CAPSULE WHICH WAS IN PIECES. HOWEVER, UPON FURTHER REVIEW OF THE IMAGES PROVIDED, IT WAS CONFIRMED THAT THE PIECES SEEN WERE NOT PART OF THE CAPSULE AND THE CAPSULE WAS INDEED INTACT. UPON LOOKING BACK AT THE JUNE 14TH X-RAY, THE APPARENT CAPSULE HAD THE SAME APPEARANCE AS ON THE 21ST, BUT THIS WAS NOT NOTED AT THE TIME OF THE X-RAY ON THE 14TH. THE PATIENT STATUS IS UNCHANGED FROM BASELINE WITH CONTINUED COMPLAINTS OF ABDOMINAL PAIN. THE PATIENT WAS SCHEDULED ORIGINALLY FOR A DOUBLE BALLOON ENDOSCOPY TO EVALUATE THE STRICTURE. THE PHYSICIAN PLANS ON REMOVING THE CAPSULE MATERIAL AT THAT TIME. THE CUSTOMER DOES NOT FEEL THIS CAPSULE IS IN THE C

  Patient problems: Abdominal Pain; Unintended Radiation Exposure

  MAUDE report 12159028 ↗
• InjuryMar 29, 2021Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, THE PATIENT WHO HAD THE PATENCY CAPSULE TWO WEEKS AGO STILL GOT THE PATENCY IN THE SMALL BOWEL. IT WAS THOUGHT ON X RAY THAT THE PATENCY WAS IN THE RECTUM SO THEY WENT AHEAD AND HAD THE CAPSULE ENDOSCOPY. BUT THEY GOT HELD UP BEHIND A STRICTURE PROBABLY IN A LOOP OF SMALL BOWEL SITTING OVER THE RECTUM. THE PATENCY WAS SEEN THRU THE CAPSULE ENDOSCOPY, SQUASHED DOWN BUT STILL THERE. IT WAS ALSO REPORTED THAT THE PILLCAM CAPSULE WAS ALSO RETAINED. THE PATIENT IS DUE FOR SURGERY TO REMOVE THE STRICTURE, PATENCY CAPSULE AND PILLCAM.

  Patient problems: Foreign Body In Patient

  MAUDE report 11581955 ↗
• InjuryMay 27, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, THE CAPSULE WAS STUCK IN THE PATIENT'S ILEUM BECAUSE THERE WAS A STENOSE. THIS WAS TYPICAL BECAUSE THE PATIENT HAS MORBUS CROHN CONDITION. THE PHYSICIAN GAVE THE PATIENT CORTISONE FOR THE CAPSULE TO COME OUT. THE CAPSULE HAD NO DEFECT AND IT WAS ALREADY EXCRETED. THE PATIENT WAS PREPPED FOR THE PROCEDURE AND A REPEAT PROCEDURE WAS NOT NECESSARY. THERE WAS NO USER HARM.

  Patient problems: Injury

  MAUDE report 10091756 ↗
• InjuryJan 2, 2020Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, THE CAPSULE WAS RETAINED. THEY CHECKED THE CAPSULE LOCATION WITH AN ABDOMINAL X-RAY WHICH SHOWED THE CAPSULE WAS STILL RETAINED IN THE SMALL BOWEL AND THE CAPSULE HAS NOT BEEN REMOVED SURGICALLY. THE PATIENT REPORTED THAT THEY CAN FEEL THE CAPSULE IN THE LOWER ABDOMINAL UMBILICAL AREA. THE PATIENT HAD A STRICTURE AND THEY NEED TO ENSURE THAT THE PATIENT HAD A PATENCY CAPSULE FIRST.

  Patient problems: Foreign Body In Patient; Radiation Exposure, Unintended

  MAUDE report 9540358 ↗
• MalfunctionNov 4, 2019Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT A PILLCAM PROCEDURE WITHOUT ANESTHESIA. DURING THE PROCEDURE, THE CAPSULE IMPACTED AN EXISTING OCCLUSION IN THE PATIENT'S DIGESTIVE TRACT. NO MEDICAL INTERVENTION WAS PERFORMED TO REMOVE THE CAPSULE. IT IS UNKNOWN WHETHER THE PATIENT HAS EXPELLED THE CAPSULE. IT WAS REPORTED THAT THE PATIENT IS DOING WELL AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 9273472 ↗
• InjuryJul 29, 2019Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, THEY HAD A PATIENT WHO HAD A RETAINED CAPSULE IN THE STOMACH FOR FIVE WEEKS. THE STOMACH WAS NOT WORKING PROPERLY AND HAD A LOT OF FOOD CONTENTS SO THEY HAD A HARD TIME RETRIEVING THE CAPSULE. THEY ASKED A RADIOLOGIST AND THE RADIOLOGIST WAS ABLE TO CLEAR THE STOMACH OF FOOD CONTENTS AND WAS ABLE TO FOLLOW WHERE THE CAPSULE WAS TRAVELLING IN THE STOMACH. THEY ARE GOING TO ATTEMPT TO RETRIEVE THE CAPSULE AGAIN NOW THAT THE STOMACH WAS CLEAR OF FOOD CONTENTS. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 8838440 ↗
• InjuryJan 8, 2019Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, A CAPSULE WAS RETAINED IN THE PATIENT. THE CAPSULE PRESENCE WAS CONFIRMED VIA X-RAY AND COLONOSCOPY AND THE DOCTOR WAS UNABLE TO REMOVE IT AND REQUESTED FOR A MEDICAL ADVISOR.

  Patient problems: Foreign Body In Patient; Radiation Exposure, Unintended

  MAUDE report 8228356 ↗
• InjuryOct 23, 2018Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, THE DOCTOR IDENTIFIED THAT THE PATIENT HAD A RETAINED CAPSULE WHEN THE DATA OR STUDY WAS REVIEWED, SO AN X-RAY AND CT SCAN WAS PERFORMED FOR CONFIRMATION OF THE CAPSULE NOT PASSING TO THE CECUM. THE PATIENT IS STILL AN INPATIENT AND IS ON TUBE FEEDING. THE PATIENT IS NOT EXPERIENCING ANY DISCOMFORT OR PAIN FROM THE CAPSULE, BUT WAS OPERATED TO OBTAIN THE RETAINED CAPSULE. A LAPAROTOMY WAS PERFORMED, THE CAPSULE WAS REMOVED AND A PARTIAL RESECTION OF THE ILEUM WAS UNDERTAKEN. THE CAPSULE WAS LOCATED LAPAROSCOPICALLY IN THE TERMINAL ILEUM WHERE IT WAS CAUGHT BY MULTIPLE BENIGN STRICTURES, CAUSED BY NONSTEROIDAL ANTI-INFLAMMATORY DRUG (NSAID) OVERUSE. THE PATIENT HAD RETURNED HOME.

  Patient problems: Injury

  MAUDE report 7996481 ↗
• MalfunctionAug 13, 2018Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, THE CAPSULE WAS BLOCKED INTO THE SMALL BOWEL OF THE PATIENT FOR MONTHS. THE PATIENT HAD BEEN UNDER RADIOTHERAPY AND THERE ARE SOME RISKS IN PERFORMING A SURGERY TO REMOVE THE CAPSULE. THEY WERE ALSO CONSIDERING IF THEY SHOULD LEAVE IT IN PLACE. THERE WAS NO MEDICAL INTERVENTION DONE AND NO PATIENT INJURY. THE CAPSULE HAS NOT BEEN EXPULSED YET AND FOR THE MOMENT IT REMAINS IN THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7777596 ↗
• InjuryMay 22, 2018Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, THE DEVICE WAS RETAINED FOR SIX MONTHS ALREADY AND WOULD NOT BE RETRIEVED BY DOUBLE BALLOON AND THEY DO NOT WANT A SURGERY AND THEY WERE GETTING TWICE YEARLY X-RAY TO MONITOR.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 7534146 ↗