Bravo FGS-0634Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 07290101369691), received between May 7, 2019 and Jul 11, 2025 — classified as 3 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2025Failure to Transmit Record; Failure to Transmit Record

  IT WAS REPORTED THAT, IN THE FIRST PART OF THE STUDY, THE RECORDER MADE A SOUND AND THE RED LIGHT TURNED ON. WHILE ON THE SECOND PART OF THE STUDY, THERE WAS NO CONNECTION WITH THE CAPSULE HOWEVER NO PARTICULAR ALARMS HAVE OCCURRED. THERE WAS NO PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22478692 ↗
• InjuryJun 22, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, THE CAPSULE WOULD NOT COMMUNICATE WITH THE RECORDER AFTER IT WAS PLACED. TESTED RECORDER WITH A DEMO CAPSULE AND IT WORKED PROPERLY AND DETERMINED THE CAPSULE WAS FAULTY. PATIENT RETURNED THE NEXT DAY AND WAS SEDATED FOR AN ADDITIONAL ENDOSCOPY PROCEDURE. HOWEVER, THE CAPSULE AGAIN INITIALLY PAIRED AND THEN LOST COMMUNICATION IN POST OP. THE ISSUE APPEARED TO BE RELATED TO A FAULTY RECORDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17181228 ↗
• InjuryMar 30, 2023Premature Discharge of Battery; Insufficient Device Problem Information; Premature Discharge of Battery; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, AFTER 3 DAYS, THE BATTERY OF THE RECORDER WENT FLAT. THE RECORDER AND CAPSULE CONNECTED BEFORE THE PATIENT LEFT. THE RECORDER NEVER ALARMED DURING THE 3 DAYS OF THE PROCEDURE BUT CONTINUOUSLY HAD A RED LIGHT ON. WHEN DELIVERED BACK TO THE HOSPITAL, THERE WAS NO RECORDING AT ALL. THE ULTRASOUND PROVED THAT THERE WAS STILL A CAPSULE IN THE COLON AND IT WAS CONNECTED TO ANOTHER RECORDER IN THE FACILITY. LAST KNOWN PATIENT STATUS IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Radiation Exposure

  MAUDE report 16643790 ↗
• MalfunctionDec 5, 2019Failure to Transmit Record; Insufficient Device Problem Information; Failure to Transmit Record; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, WHEN THEY TRIED TO UPLOAD THE STUDY ON THE RECORDER, IT HAD AN ERROR MESSAGE STATING THAT THERE MIGHT NOT BE ANY DATA ON IT. THERE WAS ALSO A MESSAGE ON THE RECORDER STATING THAT THE LAST STUDY DATA WAS NOT YET UPLOADED. THE MALFUNCTION WAS NOTICED WHEN THEY WERE DOWNLOADING THE DATA. THEY GOT A COPY OF THE ERROR. A REPEAT PROCEDURE SCHEDULED ON ANOTHER DAY WITH ADDITIONAL ANESTHESIA WAS NECESSARY. THERE WAS NO PATIENT AND USER HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9419796 ↗
• MalfunctionNov 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, THE RECORDER HAD A MISSING COVER FOR THE POWER BUTTON AND THE CHARGING PORT WAS LOOSE. TECHNICAL SUPPORT CONFIRMED THE DAMAGE ON THE RECORDER. A REPEAT PROCEDURE WAS NECESSARY SCHEDULED ON A DIFFERENT DAY. THE RECORDER WORKED CORRECTLY DURING THE PREVIOUS PROCEDURE. THERE WAS NO PATIENT OR USER HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9387597 ↗
• MalfunctionNov 22, 2019Data Problem; Data Problem

  ACCORDING TO THE REPORTER, THE RECORDER FAILED TO UPLOAD AND IT WAS NOT RECOGNIZED BY THE COMPUTER. THEY ATTEMPTED MULTIPLE TIMES, BUT IT STILL FAILED. THE RECORDER WILL BE RETURNED FOR DATA EXTRACTION AND THE RECORDER WORKED CORRECTLY DURING THE PREVIOUS PROCEDURE. A REPEAT PROCEDURE WAS NECESSARY. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: No Information

  MAUDE report 9365545 ↗
• InjuryNov 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT HAD A BURN BY THE RECORDER WHILE SLEEPING. THE PATIENT STATED THAT BURN OINTMENT WAS APPLIED TO THE BURNED AREA. THE CUSTOMER DID NOT FIND PHYSICAL OR HEAT DAMAGE TO THE RECORDER, AND THE STUDY WAS COMPETED AND WAS UPLOADED SUCCESSFULLY. THE RECORDER WORKED CORRECTLY DURING THE PREVIOUS PROCEDURE. THERE WAS NO REPEAT PROCEDURE NECESSARY.

  Patient problems: Burn(s)

  MAUDE report 9317938 ↗
• MalfunctionNov 1, 2019Noise, Audible; Noise, Audible

  ACCORDING TO THE REPORTER, THE RECORDER WAS NOT "WORKING RIGHT". THE RECORDER WAS BEEPING FOR AN EXTENDED PERIOD OF TIME. THE RECORDER WAS ADJUSTED TO FIT CLOSER TO HER CHEST BUT THE BEEPING PERSISTED. THE STUDY WILL BE PERFORMED AGAIN AS DEEMED BY THE PHYSICIAN SCHEDULED ON A DIFFERENT DAY. THE RECORDER WORKED CORRECTLY DURING THE PREVIOUS PROCEDURE. THERE WAS NO PATIENT OR USER HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9265881 ↗
• MalfunctionOct 22, 2019Failure to Power Up; Failure to Power Up

  ACCORDING TO THE REPORTER, THE RECORDER WOULD NOT POWER ON AND THERE WAS NO LED DISPLAY. TECHNICAL SUPPORT HAD THE CUSTOMER PRESS AND HOLD THE POWER BUTTON FOR SEVEN SECONDS AND THEN PRESSED THE BUTTON AGAIN, BUT THE RECORDER DID NOT POWER ON. TECHNICAL SUPPORT HAD THE CUSTOMER PRESS THE POWER BUTTON AGAIN FOR 10 SECONDS AND THEN PUSHED THE POWER BUTTON AGAIN, BUT THERE WAS STILL NO POWER OR LED DISPLAY ON THE RECORDER. TECHNICAL SUPPORT ADVISED THE CUSTOMER TO PLACE THE RECORDER ON WALL CHARGER OVERNIGHT. TECHNICAL SUPPORT CALLED THE CUSTOMER TO CONFIRM IF THE RECORDER POWERED ON AFTER CHARGING OVERNIGHT, BUT THE CUSTOMER STATED THAT THE RECORDER WAS STILL NOT POWERING ON EVEN AFTER ATTEMPTING A HARD RESET. THE DATA UPLOAD FAILED WITH ERROR AND 48.5 HOURS OF UNUSABLE DATA WAS DETECTED AT THE END OF THE STUDY WHICH WAS ALREADY REMOVED. THE RECORDER WORKED CORRECTLY DURING THE PREVIOUS PROCEDURE. THERE WAS NO PATIENT AND USER HARM AND A REPEAT PROCEDURE WAS NECESSARY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9220429 ↗
• MalfunctionOct 17, 2019Failure to Power Up; Failure to Power Up

  ACCORDING TO THE REPORTER, THE RECORDER FAILED TO POWER ON. A REPEAT PROCEDURE WAS DONE ON THE SAME DAY DUE TO DEVICE MALFUNCTION WITH NEED FOR ADDITIONAL ANESTHESIA. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: No Information

  MAUDE report 9202198 ↗
• MalfunctionOct 17, 2019Unintended Application Program Shut Down; Unintended Application Program Shut Down

  ACCORDING TO THE REPORTER, THEY HAD A SHORT STUDY. THE CUSTOMER WAS ADVISED TO SEND IN THE STUDY AND PATIENT INTERACTIONS. THE RECORDER WORKED CORRECTLY DURING PREVIOUS PROCEDURE. THE STUDY WAS REPEATED, SCHEDULED ON A DIFFERENT DAY WITH NEED FOR ADDITIONAL ANESTHESIA. THERE WAS NO PATIENT AND USER HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9202168 ↗
• MalfunctionAug 13, 2019Data Problem; Data Problem

  ACCORDING TO THE REPORTER, THE UPLOADED STUDY FILLED WITH 48.5 HOURS OF UNRECOVERABLE DATA. TECHNICAL SUPPORT LOGGED INTO THE CUSTOMER'S COMPUTER AND TOOK A SCREEN SHOT OF THE STUDY. THE RECORDER WORKED CORRECTLY DURING THE PREVIOUS PROCEDURE. THERE WAS NO PATIENT AND USER HARM AND A REPEAT PROCEDURE WAS NECESSARY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8886555 ↗
• MalfunctionJul 16, 2019Failure to Transmit Record; Insufficient Device Problem Information; Failure to Transmit Record; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, THEY WERE TRYING TO START THE STUDY, BUT IT KEPT REPEATING PROMPTS THAT THE CAPSULE COULD NOT BE PAIRED. THEY WERE UNAWARE THAT THERE WAS A SEPARATE CATHETER THAT NEEDED TO BE USED IF THEY WERE GOING TO PLACE THE CAPSULE WITHOUT CALIBRATING IT. TECHNICAL SUPPORT HAD THE CUSTOMER POWER OFF THE RECORDER AND WENT BACK THRU THE PROCESS, BUT IT KEPT REPEATING. THE RECORDER WORKED CORRECTLY DURING THE PREVIOUS PROCEDURE. THERE WAS NO PATIENT AND USER HARM AND A REPEAT PROCEDURE WAS NECESSARY USING THE CORRECT CAPSULE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8795169 ↗
• MalfunctionJun 26, 2019Failure to Transmit Record; Failure to Transmit Record

  ACCORDING TO THE REPORTER, THE RECORDER FAILED TO UPLOAD. TECHNICAL SUPPORT REMOTELY ACCESSED THE SITE AND CONFIRMED THAT THE RECORDER "STUDY TO UPLOAD". TECHNICAL SUPPORT HAD THE CUSTOMER TRY MULTIPLE PORTS, REBOOTED THE COMPUTER, RESET THE RECORDER, BUT IT STILL GAVE THE MESSAGE THAT THE UPLOAD FAILED. THE DATA EXTRACTION FAILED AS IT WOULD NOT DETECT THE RECORDER FOR UPLOAD. THE RECORDER WORKED CORRECTLY DURING THE PREVIOUS PROCEDURE. THE PATIENT HAD TO UNDERGO ANOTHER ESOPHAGOGASTRODUODENOSCOPY PROCEDURE WITH CAPSULE PLACEMENT. THERE WAS NO PATIENT OR USER HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8733387 ↗
• MalfunctionMay 7, 2019High pH; High pH

  ACCORDING TO THE REPORTER, THE STUDY HAD MULTIPLE EXCLUSIONS DUE TO HIGH PH. A REPEAT PROCEDURE WAS PERFORMED ON A DIFFERENT DAY. THE RECORDER AND WORK STATION SOFTWARE WORKED CORRECTLY DURING THE PREVIOUS PROCEDURE. THERE WAS NO PATIENT AND USER HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8586534 ↗