PillCamRecalls & reported problems across all models
Given Imaging, Inc. · 22 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 126
- Deaths reported
- 3
- Injuries reported
- 86
- Recalls
- 0
We found 22 models of PillCam by Given Imaging, Inc. in the FDA's device registry (GUDID). Together they are named in 126 adverse event reports in the FDA's MAUDE database, received between Apr 11, 2018 and Sep 18, 2026 — classified as 3 deaths, 86 injuries, 37 malfunctions.
The most frequently reported specific device problem is “Entrapment of Device” (67 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported PillCam problems
Device problems
- Entrapment of Device67
- Adverse Event Without Identified Device or Use Problem14
- Human-Device Interface Problem14
- Unintended Application Program Shut Down12
- Failure to Transmit Record8
- Insufficient Device Problem Information7
- Material Fragmentation6
- Loss of Power4
Patient problems
- Radiation Exposure, Unintended33
- Foreign Body In Patient24
- No Clinical Signs, Symptoms or Conditions14
- Unintended Radiation Exposure14
- No Consequences Or Impact To Patient13
- Abdominal Pain11
- No Known Impact Or Consequence To Patient11
- No Information6
PillCam models
22 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PillCam FGS-0501SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE27 reports
- PillCam FGS-0391SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE2 deaths17 reports
- Pillcam FGS-0109SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE13 reports
- PillCam FGS-0400SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE11 reports
- Pillcam FGS-0347SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE1 death10 reports
- Pillcam FGS-0497SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE9 reports
- PillCam FGS-0500SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE8 reports
- PillCam FGS-0517Colon capsule imaging system7 reports
- PillCam FGS-0155SYSTEM, IMAGING, ESOPHAGEAL, WIRELESS, CAPSULE3 reports
- PillCam FGS-0668SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE3 reports
- Pillcam FGS-0110SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE2 reports
- Pillcam FGS-0355SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE2 reports
- PillCam FGS-0498SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE2 reports
- PillCam FGS-0499SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE2 reports
- PillCam FGS-0568SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE2 reports
- PillCam FGS-0662SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE2 reports
- Pillcam FGS-0362SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE1 report
- PillCam RFB-0347SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE1 report
- PillCam FGS-0519Colon capsule imaging system1 report
- PillCam FGS-0591SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE1 report
- PillCam FGS-0661SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE1 report
- PillCam FGS-0667SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE1 report
Recent PillCam adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Overheating of Device; Ambient Noise Problem; Insufficient Device Problem Information
It was reported that the belt and the electronic pack were vibrating excessively and it was hot to touch. When looking at the screen, there were times where the icon on the top of screen would switch to red. Took off the belt as did not feel it was safe to keep on the patient. There was no patient or user harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50816594 ↗InjurySep 17, 2026Entrapment of Device
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 50805764 ↗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 ↗MalfunctionApr 14, 2026Overheating of Device; Insufficient Device Problem Information
IT WAS REPORTED THAT THE RECORDER BECAME WARM WHEN IT STOPPED WORKING BEFORE 9 PM. THE PATIENT WAS JUST SITTING WHEN THE INCIDENT OCCURRED AND THE PATIENT DID NOT SUSTAIN A BURN. THE STUDY WAS COMPLETED IN 10 HOURS. THERE WAS NO PATIENT OR USER HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24872834 ↗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 ↗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 ↗MalfunctionSep 2, 2025Human-Device Interface Problem; Human-Device Interface Problem
IT WAS REPORTED THAT A PATIENT COULD NOT SWALLOW THE CAPSULE AFTER TWO ATTEMPTS. THE PATIENT EXPERIENCED COUGHING, GAGGING AND SOME CHEST DISCOMFORT. THE PATIENT GAGGED AND THREW UP THE CAPSULE.
Patient problems: Choking; Discomfort
MAUDE report 22937172 ↗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 ↗MalfunctionAug 11, 2025Smoking; Smoking
IT WAS REPORTED THAT THE CRADLE WAS SMOKING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22770479 ↗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 ↗MalfunctionApr 30, 2025Smoking; Smoking
IT WAS REPORTED THAT THE CUSTOMER WAS HAVING PROBLEMS GETTING THE CRADLE TO POWER ON. POWER CORDS OF THE CRADLE WERE CHANGED AND THE CRADLE STARTED TO SMOKE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21937420 ↗MalfunctionApr 30, 2025Smoking; Insufficient Device Problem Information; Smoking; Insufficient Device Problem Information
IT WAS REPORTED THAT THE CUSTOMER WAS HAVING PROBLEMS GETTING THE CRADLE TO POWER ON. POWER CORDS OF THE CRADLE WERE CHANGED AND THE CRADLE STARTED TO SMOKE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21936389 ↗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 ↗
Other Given Imaging, Inc. products
All Given Imaging, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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