Bravo FGS-0312Recalls & reported problems

Summary

The FDA's MAUDE database contains 125 adverse event reports that list this exact device (DI 07290101361695), received between Mar 29, 2017 and Mar 28, 2025 — classified as 7 injuries, 118 malfunctions.

The most frequently reported specific device problem is “Failure To Adhere Or Bond” (59 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 25 most recent of 125 reports, in the reporter's own words as published by the FDA.

• InjuryMar 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED PAIN WITH EATING AND DRINKING ONCE THE RECORDER WAS RETURNED. AN X-RAY WAS PERFORMED ON (B)(6), AND THE CAPSULE FELL OFF SOMETIME AROUND THE (B)(6). THE PATIENT REPORTED SYMPTOMS OF RHEUMATOID ARTHRITIS, WHICH HAD BEEN IN REMISSION FOR 12 YEARS SINCE THE CAPSULE WAS PLACED. THE PATIENT HAD AN APPOINTMENT WITH A RHEUMATOLOGIST.

  Patient problems: Arthritis; Pain

  MAUDE report 21720051 ↗
• InjuryNov 2, 2023

  BRAVO IMPLANT STUCK IN WALL OF ESOPHAGUS AFTER 17 DAYS OF IMPLANTING. CHEST PAIN AND TROUBLE SWALLOWING. NEED FURTHER MEDICAL SERVICES TO REMOVE. CHANCING ESOPHAGUS WALL BEING DAMAGED. HAD BRAVO IMPLANT PUT IN OCTOBER 4. CHEST PAINS AND TROUBLE 16 DAYS LATER. NEED TO SCHEDULE ENDOSCOPY TO HAVE REMOVED OFF OF ESOPHAGUS WALL CHANCING TEARING OF THE LINING OF ESOPHAGUS.

  Patient problems: Chest Pain; Dysphagia/ Odynophagia; Foreign Body In Patient

  MAUDE report 18066873 ↗
• MalfunctionDec 6, 2021Positioning Failure; Positioning Failure

  ACCORDING TO THE REPORTER, THEY HAD A CAPSULE WHICH FAILED TO ATTACH. THE CAPSULE COULDN'T BE DELIVERED. IT WAS STILL ON CATHETER WHEN PHYSICIAN TRIED TO REMOVED THE CATHETER. PATIENT WAS UNDER ANESTHESIA AND REPEAT PROCEDURE NEEDED. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12933576 ↗
• MalfunctionMar 22, 2021Positioning Failure; Positioning Failure

  ACCORDING TO THE REPORTER, THEY HAD A CAPSULE WHICH FAILED TO ATTACH. THERE WAS NO HARM TO THE PATIENT AND THE USER, NO INTERVENTION WAS REQUIRED. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT OR THE PROCEDURE AND AN ENDOSCOPY HAD BEEN PERFORMED PRIOR TO THE PROCEDURE AND SHOWED THE ESOPHAGUS TO BE NORMAL. NO LUBRICATION WAS USED TO FACILITATE PLACEMENT OF THE CAPSULE AND THE DELIVERY SYSTEM AND CAPSULE WILL BE RETURNED FOR INVESTIGATION.

  Patient problems: Airway Obstruction

  MAUDE report 11541980 ↗
• MalfunctionMar 2, 2021Positioning Failure; Positioning Failure

  ACCORDING TO THE REPORTER, WHEN THE CAPSULE WAS DEPLOYED, IT FAILED TO ATTACH TO THE MUCOSA. AS A RESULT, THE PROCEDURE WAS REPEATED WITH A BRAVO CAPSULE FOR A DIFFERENT BATCH AND THE CAPSULE ATTACHED WITHOUT ISSUE. THERE WAS NO HARM TO THE PATIENT AND THE USER. NO INTERVENTION WAS REQUIRED. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT OR THE PROCEDURE, AND AN ENDOSCOPY HAD BEEN PERFORMED PRIOR TO THE PROCEDURE THAT SHOWED THE ESOPHAGUS TO BE NORMAL. NO LUBRICATION WAS USED TO FACILITATE PLACEMENT OF THE CAPSULE. THE PATIENT RECEIVED AN IV SEDATION FOR THE INITIAL PROCEDURE. A SECOND CAPSULE WAS USED ON THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11398401 ↗
• MalfunctionJan 29, 2021Positioning Failure; Positioning Failure

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE CAPSULE WAS DELIVERED ENDOSCOPICALLY, BUT IT DISLODGED ON FIRST ATTEMPT. A SECOND CAPSULE WAS CALIBRATED, AND THE SAME MALFUNCTION OCCURRED WITH SECOND CAPSULE. SECOND CAPSULE PLACEMENT WAS ATTEMPTED DURING THE SAME PROCEDURE. AFTER THE SECOND CAPSULE FAILED TO ATTACH, THEY DECIDED TO ABANDON THE PROCEDURE. THE CUSTOMER HAD ALSO CONFIRMED THAT ALL SUCTION WAS WORKING CORRECTLY AND CHECKED AS PER INSTRUCTIONS PRIOR TO DEPLOYMENT OF THE CAPSULE. THE CAPSULES WERE UNABLE TO BE COLLECTED AS THEY WERE INSIDE THE PATIENT AND WILL BE EXCRETED AT SOME POINT BUT NOT RETAINED. THE PATIENT WAS PREPPED FOR PROCEDURE. AS PATIENT WAS UNDER SEDATION, THE PROCEDURE WAS ABANDONED DUE TO TIME CONSTRAINTS OF CALIBRATION VERSUS PATIENT TIME SEDATED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11250176 ↗
• MalfunctionOct 30, 2020Positioning Failure; Positioning Failure

  ACCORDING TO THE REPORTER, THEY HAD A CAPSULE WHICH FAILED TO ATTACH. THERE WAS NO HARM TO THE PATIENT AND THE USER, NO INTERVENTION WAS REQUIRED. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT OR THE PROCEDURE AND AN ENDOSCOPY HAD BEEN PERFORMED PRIOR TO THE PROCEDURE AND SHOWED THE ESOPHAGUS TO BE NORMAL. LUBRICATION WAS USED TO FACILITATE PLACEMENT OF THE CAPSULE AND THE DELIVERY SYSTEM AND CAPSULE WILL BE RETURNED FOR INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10761910 ↗
• MalfunctionSep 22, 2020Failure to Transmit Record; Failure to Transmit Record

  ACCORDING TO THE REPORTER, THE CAPSULE FAILED TO TRANSMIT. THEY PLACED THE CAPSULE AND THE RECORDER SWITCHED BACK TO CALIBRATE. THERE WAS NO PATIENT AND USER HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10565572 ↗
• MalfunctionJul 13, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, THEY HAD A CAPSULE WHICH FAILED TO ATTACH. THERE WAS NO HARM TO THE PATIENT AND NO INTERVENTION WAS REQUIRED. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT OR THE PROCEDURE AND AN ENDOSCOPY HAD BEEN PERFORMED PRIOR TO THE PROCEDURE AND SHOWED THE ESOPHAGUS TO BE NORMAL. NO LUBRICANT WAS USED TO FACILITATE PLACEMENT OF THE CAPSULE AND THE DELIVERY SYSTEM AND CAPSULE WILL BE RETURNED FOR INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10263233 ↗
• MalfunctionJun 1, 2020Loss of or Failure to Bond; Positioning Failure; Loss of or Failure to Bond; Positioning Failure

  ACCORDING TO THE REPORTER, THE CAPSULE FAILED TO ATTACH. THERE WAS NO PATIENT AND USER HARM AND NO INTERVENTION WAS REQUIRED. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT OR THE PROCEDURE AND AN ENDOSCOPY HAD BEEN PERFORMED PRIOR TO THE PROCEDURE AND SHOWED THE ESOPHAGUS TO BE NORMAL. NO LUBRICANT WAS USED TO FACILITATE PLACEMENT OF THE CAPSULE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10104118 ↗
• MalfunctionMar 11, 2020Loss of or Failure to Bond; Positioning Failure; Loss of or Failure to Bond; Positioning Failure

  ACCORDING TO THE REPORTER, THEY HAD A CAPSULE, WHICH FAILED TO ATTACH. THERE WAS NO HARM TO THE PATIENT AND USER. NO INTERVENTION WAS REQUIRED. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT OR THE PROCEDURE AND AN ENDOSCOPY HAD BEEN PERFORMED PRIOR TO THE PROCEDURE AND SHOWED THE ESOPHAGUS TO BE NORMAL. LUBRICATION WAS USED TO FACILITATE PLACEMENT OF THE CAPSULE AND THE DELIVERY SYSTEM AND CAPSULE WILL BE RETURNED FOR INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9821883 ↗
• MalfunctionFeb 12, 2020Loss of or Failure to Bond; Positioning Failure; Loss of or Failure to Bond; Positioning Failure

  ACCORDING TO THE REPORTER, THE CAPSULE FAILED TO ATTACH. THERE WAS NO PATIENT AND USER HARM AND NO INTERVENTION WAS REQUIRED. THEY CALIBRATED ANOTHER CAPSULE TO COMPLETE THE PROCEDURE. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT OR THE PROCEDURE AND AN ENDOSCOPY HAD BEEN PERFORMED PRIOR TO THE PROCEDURE AND SHOWED THE ESOPHAGUS TO BE NORMAL. LUBRICATION WAS USED TO FACILITATE PLACEMENT OF THE CAPSULE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9700773 ↗
• InjuryDec 20, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, THE CAPSULE FAILED TO DEPLOY FROM THE CATHETER AFTER IT WAS CLIPPED WHICH CAUSED TEAR IN ESOPHAGUS. THE EVENT REQUIRED CLIPS TO FIX THE ESOPHAGEAL TEAR. A REPEAT PROCEDURE ON ANOTHER DAY WAS NOT NECESSARY.

  Patient problems: Laceration(s) of Esophagus

  MAUDE report 9505965 ↗
• InjuryDec 19, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, THE CAPSULE FAILED TO ATTACH. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Blood Loss; Injury; No Information

  MAUDE report 9492948 ↗
• MalfunctionDec 19, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, THE CAPSULE FAILED TO ATTACH TO THE PATIENT'S ESOPHAGUS. THERE WAS NO HARM TO THE PATIENT; NO INTERVENTION WAS REQUIRED. THE PROCEDURE WAS REPEATED. PRIOR TO THE PROCEDURE, AN ENDOSCOPY WAS PERFORMED AND SHOWED THE ESOPHAGUS TO BE NORMAL. NO LUBRICATION WAS USED TO FACILITATE PLACEMENT OF THE CAPSULE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9492304 ↗
• MalfunctionNov 11, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, THEY HAD A CAPSULE WHICH FAILED TO ATTACH. THERE WAS NO HARM TO THE PATIENT, NO INTERVENTION WAS REQUIRED, AND A REPEAT PROCEDURE WAS NOT PERFORMED. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT OR THE PROCEDURE AND AN ENDOSCOPY HAD BEEN PERFORMED PRIOR TO THE PROCEDURE AND SHOWED THE ESOPHAGUS TO BE NORMAL. LUBRICATION WAS USED TO FACILITATE PLACEMENT OF THE CAPSULE AND THE DELIVERY SYSTEM AND CAPSULE WILL BE RETURNED FOR INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9307001 ↗
• MalfunctionOct 31, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, THEY HAD A CAPSULE WHICH FAILED TO ATTACH. THERE WAS NO HARM TO THE  USER AND PATIENT. A REPEAT PROCEDURE WAS PERFORMED WHEREIN FORCEPS WERE USED AS AN INTERVENTION TO RETRIEVE THE CAPSULE AND A DIFFERENT CAPSULE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT OR THE PROCEDURE AND AN ENDOSCOPY HAD BEEN PERFORMED PRIOR TO THE PROCEDURE AND SHOWED THE ESOPHAGUS TO BE NORMAL. THE PHYSICIAN USED A SCOPE FOR CAPSULE PLACEMENT. THE DELIVERY SYSTEM AND CAPSULE WILL BE RETURNED FOR INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9263765 ↗
• MalfunctionJun 26, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, THEY HAD A CAPSULE WHICH FAILED TO ATTACH. THE PATIENT WAS PREPPED FOR THE PROCEDURE AND A REPEAT PROCEDURE WAS PERFORMED, BUT THERE WAS NO REPORTED PATIENT OUTCOME. THE DELIVERY SYSTEM AND CAPSULE WILL BE RETURNED FOR INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 8733380 ↗
• MalfunctionJun 17, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, THE PHYSICIAN THOUGHT THE CAPSULE WAS CORRECTLY ATTACHED, THEN CHECKED WITH AN ENDOSCOPE AND FOUND OUT THAT THE CAPSULE FAILED TO ATTACH. THEY WERE ABLE TO RECOVER THE CAPSULE. NO REPEAT PROCEDURE ON A DIFFERENT DAY WAS NEEDED AS THEY USED ANOTHER CAPSULE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8706177 ↗
• MalfunctionMay 23, 2019Failure to Transmit Record; Failure to Transmit Record

  ACCORDING TO THE REPORTER, THEY HAD A CAPSULE WHICH FAILED TO ATTACH. ANOTHER CAPSULE WAS OPENED, BUT THE CUSTOMER WAS UNABLE TO CANCEL THE FIRST STUDY THAT WAS STARTED ON THE RECORDER. A REPEAT PROCEDURE WAS SCHEDULED ON A DIFFERENT DAY. THE CUSTOMER STATED THAT RECORDER WORKED CORRECTLY DURING THE PREVIOUS PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8637923 ↗
• MalfunctionApr 30, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, THEY HAD A CAPSULE WHICH FAILED TO ATTACH. THERE WAS NO HARM TO THE PATIENT, NO INTERVENTION WAS REQUIRED, AND A REPEAT PROCEDURE WAS PERFORMED. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT OR THE PROCEDURE, THE PHYSICIAN USED A SCOPE TO DETERMINE CAPSULE PLACEMENT, AND AN ENDOSCOPY HAD BEEN PERFORMED PRIOR TO THE PROCEDURE AND SHOWED THE ESOPHAGUS TO BE NORMAL. NO LUBRICATION WAS USED TO FACILITATE PLACEMENT OF THE CAPSULE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8567494 ↗
• MalfunctionApr 15, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, THEY HAD A CAPSULE WHICH FAILED TO ATTACH AND THE PATIENT HAD A TEAR ON THE ESOPHAGEAL WALL. AFTER FIRING OF THE CAPSULE AND THE DELIVERY SYSTEM HAS BEEN REMOVED, THE CAPSULE FAILED TO ATTACH ON THE ESOPHAGEAL WALL AND THE CAPSULE WENT TO THE PATIENT'S STOMACH.THERE WAS NO INTERVENTION REQUIRED, AND ANOTHER CAPSULE WAS USED TO REPEAT THE PROCEDURE ON THE SAME DAY. THE PATIENT WAS NOT OVERLY SEDATED, BUT THE ANESTHESIA WAS UNABLE TO CONTROL THE PATIENT WELL AND THE PATIENT GOT IRRITATED BY THE PROCEDURE. PATIENT WAS MOVING DURING VACUUM SUCTION APPLIED AND EVEN THE FIRING PROCEDURE. AN ENDOSCOPY HAD BEEN PERFORMED PRIOR TO THE PROCEDURE AND SHOWED THE ESOPHAGUS TO BE NORMAL. A LUBRICANT WAS USED TO FACILITATE PLACEMENT OF THE CAPSULE. THE PATIENT WAS PREPPED FOR THE PROCEDURE AND WAS UNDER ANESTHESIA.

  Patient problems: Laceration(s) of Esophagus

  MAUDE report 8513749 ↗
• MalfunctionMar 27, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, THE CAPSULE FAILED TO ATTACH ON THE PATIENT'S ESOPHAGUS. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 8458583 ↗
• MalfunctionMar 27, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, WHEN THEY FIRED DURING THE PROCEDURE, THE CAPSULE FAILED TO ATTACH ON THE ESOPHAGEAL WALL OF THE PATIENT, AND THE CAPSULE WAS REMOVED BY THE USE OF THE DELIVER CATHETER. THE PHYSICIAN NOTICED BLOOD ON ESOPHAGEAL WALL AND MENTIONED THAT THERE WAS A MILD TEAR, AND NO INTERVENTION WAS NEEDED TO TREAT THE TEAR. NO REPEAT PROCEDURE WAS DONE ON A DIFFERENT DAY AS ANOTHER CAPSULE WAS USED TO PROCEED WITH THE PROCEDURE. THE CUSTOMER NOTED THE PATIENT WAS NOT UNDER ANESTHESIA.

  Patient problems: No Code Available

  MAUDE report 8457544 ↗
• MalfunctionMar 21, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, THEY HAD A CAPSULE WHICH FAILED TO ATTACH. NO INTERVENTION WAS REQUIRED, AND A REPEAT PROCEDURE WAS NOT NECESSARY. ANOTHER CAPSULE WAS USED TO PROCEED WITH THE PROCEDURE. WHEN THE DOCTOR WAS PERFORMING THE ENDOSCOPY PRIOR TO THE PROCEDURE THE PATIENT WAS COUGHING AND IT SHOWED THAT THE ESOPHAGUS WAS NORMAL. NO LUBRICATION WAS USED TO FACILITATE PLACEMENT OF THE CAPSULE. THERE WAS NO USER HARM.

  Patient problems: No Code Available

  MAUDE report 8439465 ↗