Bravo FGS-0636Recalls & reported problems

Summary

The FDA's MAUDE database contains 820 adverse event reports that list this exact device (DI 07290101369714), received between May 1, 2019 and Jul 13, 2026 — classified as 156 injuries, 664 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (567 reports).

2 FDA recall records name this device's identifier, 2 still open.

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.

Recalls naming this device

1. Aug 6, 2026Class IOpen, Classified

   Capsule may fail to attach to the esophagus or detach from the delivery device. Risks include patient aspiration/inhalation, perforation of esophagus, obstruction of the airway, hemorrhage/blood loss/bleeding, laceration of the esophagus, a delay in diagnosis, and foreign bodies remaining in the patient.

   Z-3090-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

2. Jun 3, 2025Class IOpen, Classified

   It has been determined that misapplied adhesive on the Bravo CF capsule delivery device may lead to its malfunction. Specifically, the misapplied adhesive may prevent the capsule from attaching to the patient's esophagus or detaching from the delivery device.

   Z-2047-2025 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 820 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 13, 2026Separation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25802087 ↗
• InjuryJul 13, 2026Positioning Failure

  IT WAS REPORTED THAT THE FIRST CAPSULE FAILED TO ATTACH TO THE PATIENT'S ESOPHAGUS. THE FIRST CAPSULE WAS FOUND IN THE ESOPHAGUS AND WAS RETRIEVED WITH A 3-PRONG RECOVERY DEVICE. A SECOND CAPSULE WAS USED AND STILL FAILED TO ATTACH. THE SECOND CAPSULE REMAINED ATTACH TO THE DELIVERY DEVICE WHEN IT WAS REMOVED AND THEN FELL OFF THE DELIVERY DEVICE. NO LUBRICATION WAS USED TO FACILITATE THE PLACEMENT OF THE CAPSULE.

  Patient problems: Foreign Body In Patient

  MAUDE report 25801915 ↗
• MalfunctionMay 14, 2026Positioning Failure

  IT WAS REPORTED THAT THE CAPSULE FAILED TO ATTACH TO THE PATIENT'S ESOPHAGUS AFTER FOLLOWING THE CORRECT STEPS OF 30 SECONDS SUCTION OF AT LEAST 550MMHG. CAPSULE WAS NOT AT THE DESIRED LOCATION BUT NOT WITH THE DELIVERY DEVICE ANYMORE WHEN PHYSICIAN WENT IN WITH SCOPE TO CHECK. DEPLOYED CAPSULE FOUND AT THE PATIENT'S MOUTH AND WAS RETRIEVED BY HANDS. A SECOND CAPSULE OF THE SAME LOT NUMBER WAS DEPLOYED SUCCESSFULLY. THERE WAS NO PATIENT OR USER HARM.

  Patient problems: Airway Obstruction

  MAUDE report 25173436 ↗
• InjuryMay 12, 2026Positioning Failure

  IT WAS REPORTED THAT THE FIRST CAPSULE WAS DEPLOYED WITH A SUCTION TIME OF 1 MINUTE AND THE VACUUM PUMP PRESSURE REACHED 550 MMHG USING SUCTION AND THE CAPSULE FAILED TO ATTACH TO THE ESOPHAGUS AND DROPPED INTO THE PATIENT¿S STOMACH. THE CAPSULE WAS RETRIEVED FROM THE STOMACH USING A ROTH NET. THE SAME ISSUE OCCURRED WITH A SECOND CAPSULE AND ALSO DROPPED INTO THE PATIENT¿S STOMACH. A THIRD CAPSULE WAS THEN USED, AND THE SUCTION TIME WAS EXTENDED TO 2 MINUTES, AFTER WHICH THE THIRD CAPSULE WAS SUCCESSFULLY DEPLOYED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25150880 ↗
• MalfunctionMay 12, 2026Positioning Failure

  IT WAS REPORTED THAT THE FIRST CAPSULE WAS DEPLOYED WITH A SUCTION TIME OF 1 MINUTE AND THE VACUUM PUMP PRESSURE REACHED 550 MMHG USING SUCTION AND THE CAPSULE FAILED TO ATTACH TO THE ESOPHAGUS AND DROPPED INTO THE PATIENT¿S STOMACH. THE CAPSULE WAS RETRIEVED FROM THE STOMACH USING A ROTH NET. THE SAME ISSUE OCCURRED WITH A SECOND CAPSULE AND ALSO DROPPED INTO THE PATIENT¿S STOMACH. A THIRD CAPSULE WAS THEN USED, AND THE SUCTION TIME WAS EXTENDED TO 2 MINUTES, AFTER WHICH THE THIRD CAPSULE WAS SUCCESSFULLY DEPLOYED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25150729 ↗
• MalfunctionMar 16, 2026Separation Failure

  IT WAS REPORTED THAT THE CAPSULE ATTACHED TO THE ESOPHAGUS BUT FAILED TO DETACH FROM THE DELIVERY DEVICE. THERE WAS NO PATIENT AND USER HARM, AND NO INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24610289 ↗
• MalfunctionFeb 27, 2026Separation Failure

  IT WAS REPORTED THAT THE CAPSULE FAILED TO ATTACH TO THE PATIENT'S ESOPHAGUS AND WAS STILL ATTACHED TO THE DELIVERY DEVICE. THERE WAS NO PATIENT OR USER HARM. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT OR THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24470301 ↗
• InjuryFeb 11, 2026Positioning Failure

  IT WAS REPORTED THAT THE CAPSULE FAILED TO ATTACH AND WAS FOUND IN THE PATIENT'S ESOPHAGUS. THE CAPSULE WAS RETRIEVED USING MCGILL'S FORCEPS. A SECOND CAPSULE ATTACHED SUCCESSFULLY ON THE SAME PROCEDURE. LUBRICATION WAS USED TO FACILITATE THE PLACEMENT OF THE CAPSULE. INTUBATION WAS DONE TO PROVIDE AIRWAY SUPPORT TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24313090 ↗
• MalfunctionFeb 2, 2026Separation Failure

  IT WAS REPORTED THAT THE CAPSULE FAILED TO DETACH FROM THE DELIVERY DEVICE. THE CAPSULE WAS STILL ATTACHED TO THE DELIVERY DEVICE WHEN IT WAS REMOVED FROM THE PATIENT. THE RUBBER TIP ON THE DELIVERY DEVICE WAS BENT BACK, WHICH CAUSED SOME BLEEDING AND PAIN TO THE PATIENT. ANOTHER CAPSULE WAS USED AND IT ATTACHED SUCCESSFULLY. ADDITIONAL SEDATION HAD TO BE GIVEN TO THE PATIENT DUE TO THE ISSUE. LUBRICATION WAS USED TO FACILITATE THE PLACEMENT OF THE CAPSULE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 24235564 ↗
• MalfunctionJan 26, 2026

  BRAVO CAPSULE FAILED TO DEPLOY. NORMAL OPERATIONS PERFORMED. CAPSULE WAS REMOVED BY DR. AS CAPSULE DROPPED INTO MOUTH WHEN THE DELIVERY DEVICE WAS REMOVED. SECOND BRAVO CAPSULE AND DELIVERY DEVICE WAS OBTAINED AND PLACED WITHOUT ANY ISSUE. DR. [REDACTED] WAS THE PHYSICIAN IN THE ROOM.

  Patient problems: Insufficient Information

  MAUDE report 24176807 ↗
• MalfunctionJan 16, 2026Separation Failure

  IT WAS REPORTED THAT THE CAPSULE FAILED TO ATTACH TO THE PATIENT¿S ESOPHAGUS AND WAS STILL ATTACHED TO THE DELIVERY DEVICE UPON REMOVAL. THEY PLACED A SECOND CAPSULE ON THE SAME PROCEDURE AND STILL DID NOT ATTACH. THE SECOND CAPSULE WAS STILL LOOSELY ATTACHED TO THE DELIVERY DEVICE UPON REMOVAL. THEY PLACED A THIRD CAPSULE ON THE SAME PROCEDURE AND ATTACHED SUCCESSFULLY. LUBRICATION WAS USED TO FACILITATE THE PLACEMENT OF THE CAPSULE. THERE WAS NO PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24094118 ↗
• MalfunctionJan 16, 2026Separation Failure

  IT WAS REPORTED THAT THE CAPSULE FAILED TO ATTACH TO THE PATIENT¿S ESOPHAGUS AND WAS STILL ATTACHED TO THE DELIVERY DEVICE UPON REMOVAL. THEY PLACED A SECOND CAPSULE ON THE SAME PROCEDURE AND STILL DID NOT ATTACH. THE SECOND CAPSULE WAS STILL LOOSELY ATTACHED TO THE DELIVERY DEVICE UPON REMOVAL. THEY PLACED A THIRD CAPSULE ON THE SAME PROCEDURE AND ATTACHED SUCCESSFULLY. LUBRICATION WAS USED TO FACILITATE THE PLACEMENT OF THE CAPSULE. THERE WAS NO PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24094108 ↗
• MalfunctionJan 16, 2026Separation Failure

  IT WAS REPORTED THAT THE CAPSULE FAILED TO ATTACH. THE DELIVERY DEVICE WAS WITHDRAWN, AND THE CAPSULE FELL TO THE FLOOR AS THE DELIVERY DEVICE LEFT THE MOUTH. ANOTHER CAPSULE WAS ATTEMPTED TO BE USED AND IT WAS UNSUCCESSFUL. ADDITIONAL PROPOFOL ANESTHESIA TIME WAS NEEDED DUE TO THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Oversedation

  MAUDE report 24094087 ↗
• MalfunctionJan 16, 2026Positioning Failure; Separation Failure

  IT WAS REPORTED THAT THE CAPSULE FAILED TO ATTACH. THE DELIVERY DEVICE WAS WITHDRAWN, AND THE CAPSULE FELL TO THE FLOOR AS THE DELIVERY DEVICE LEFT THE MOUTH. ANOTHER CAPSULE WAS ATTEMPTED TO BE USED AND IT WAS UNSUCCESSFUL AS THE SAME ISSUE OCCURRED. THE SECOND CAPSULE CAME OUT ON THE DELIVERY DEVICE LOOSELY ATTACHED. ADDITIONAL PROPOFOL ANESTHESIA TIME WAS NEEDED DUE TO THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Oversedation

  MAUDE report 24094075 ↗
• InjuryDec 19, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE CAPSULE FAILED TO ATTACH TO THE PATIENT¿S ESOPHAGUS AND FOUND IN THE PATIENT¿S ESOPHAGUS. THE CAPSULE WAS RETRIEVED USING A ROTH NET. THEY PLACED ANOTHER CAPSULE ON THE SAME PROCEDURE AND ATTACHED SUCCESSFULLY. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT OR THE PROCEDURE. NO LUBRICATION WAS USED TO FACILITATE PLACEMENT OF THE CAPSULE.

  Patient problems: Foreign Body In Patient

  MAUDE report 23848994 ↗
• MalfunctionNov 21, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO INSERT THE CAPSULE ENDOSCOPICALLY, BUT THE CAPSULE DID NOT ATTACH IN THE DESIRED POSITION AND DETACHED, MAKING IT IMPOSSIBLE TO COMPLETE THE EXAMINATION. THE PATIENT REMAINED STABLE AND CONTINUED TO RECEIVE POST-SEDATION CARE. THERE WAS NO PATIENT OR USER HARM.

  Patient problems: Airway Obstruction; Foreign Body In Patient

  MAUDE report 23616616 ↗
• InjuryNov 6, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE CAPSULE FAILED TO ATTACH TO THE PATIENT¿S ESOPHAGUS AND FOUND IN THE PATIENT¿S ORAL PHARYNX. THE CAPSULE WAS RETRIEVED WITH A SNARE. NO LUBRICATION WAS USED TO FACILITATE THE PLACEMENT OF THE CAPSULE.

  Patient problems: Airway Obstruction

  MAUDE report 23485875 ↗
• MalfunctionNov 4, 2025Separation Failure; Separation Failure

  IT WAS REPORTED THAT THE CAPSULE DID ATTACH TO THE ESOPHAGUS, BUT THE DOCTOR HAD TO BREAK THE HANDLE TO RELEASE THE CAPSULE FROM THE DELIVERY DEVICE. LUBRICATION WAS USED TO FACILITATE THE PLACEMENT OF THE CAPSULE. THERE WAS NO PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23464933 ↗
• MalfunctionSep 26, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT ONCE THE CAPSULE WAS PLACED, IT WAS CHECKED WITH AN ENDOSCOPE. THE CAPSULE HAD MOVED, COMING LOOSE FROM ITS ANCHORING LOCATION, AND WAS FOUND IN THE PATIENT'S ESOPHAGUS. ANOTHER CAPSULE WAS USED DURING THE SAME PROCEDURE, AND IT ATTACHED SUCCESSFULLY. THERE WAS NO PATIENT OR USER HARM, AND NO INTERVENTION WAS REQUIRED. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT OR THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 23154338 ↗
• MalfunctionSep 16, 2025Separation Failure; Separation Failure

  IT WAS REPORTED THAT THE CAPSULE FAILED TO DETACH FROM THE DELIVERY DEVICE. THE PHYSICIAN BROKE THE HANDLE DURING THE PROCEDURE, AND THE CAPSULE WAS STILL ATTACHED TO THE DELIVERY DEVICE WHEN IT WAS REMOVED FROM THE PATIENT. THERE WAS NO PATIENT OR USER HARM. NO LUBRICATION WAS USED TO FACILITATE THE PLACEMENT OF THE CAPSULE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23063980 ↗
• MalfunctionSep 15, 2025Separation Failure; Separation Failure

  IT WAS REPORTED THAT THE CAPSULE FAILED TO ATTACH TO THE ESOPHAGUS AS IT WAS STILL ATTACHED TO THE DELIVERY DEVICE WHEN IT WAS REMOVED FROM THE PATIENT, SO THE PHYSICIAN HAD TO BREAK THE HANDLE. THE DEPLOYMENT DEVICE WAS INSERTED WITH THE CAPSULE FACING THE TONGUE AND WHILE THE ENTIRE DEVICE INCLUDING THE HANDLE WAS MAINTAINED IN THE HORIZONTAL PLANE. LUBRICANT WAS USED AND WAS CAREFULLY APPLIED TO AVOID COVERING THE SUCTION CHAMBER. THERE WAS NO PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23051176 ↗
• MalfunctionSep 11, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A PATIENT HAD A RETAINED CAPSULE LOCATED IN THE SMALL BOWEL. THERE WAS NO PATIENT OR USER HARM.

  Patient problems: Foreign Body In Patient

  MAUDE report 23025985 ↗
• InjurySep 2, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE CAPSULE FAILED TO ATTACH AND WAS FOUND IN THE PATIENT'S ESOPHAGUS AND WAS RETRIEVED USING A ROTHNET. ANOTHER CAPSULE WAS SUCCESSFULLY PLACED ON THE SAME PROCEDURE. THE PHYSICIAN VERIFIED THE CAPSULE PLACEMENT ENDOSCOPICALLY. A LUBRICANT WAS USED, AND IT WAS CAREFULLY APPLIED TO AVOID COVERING THE SUCTION CHAMBER.

  Patient problems: Foreign Body In Patient

  MAUDE report 22948876 ↗
• InjuryAug 14, 2025Positioning Failure; Positioning Failure

  ACCORDING TO THE REPORTER, THEY HAD A CAPSULE WHICH FAILED TO ATTACH TO THE PATIENT¿S ESOPHAGUS AND WAS FOUND IN THE PATIENT¿S STOMACH. THE CAPSULE WAS RETRIEVED USING A ROTH NET. A SECOND CAPSULE WAS PLACED SUCCESSFULLY. THE PHYSICIAN VERIFY THE CAPSULE PLACEMENT ENDOSCOPICALLY AND SEEN IT WAS NOT ATTACHED. LUBRICATION WAS USED TO FACILITATE THE PLACEMENT OF THE CAPSULE. THERE WAS NO PATIENT AND USER HARM, AND NO INTERVENTION WAS REQUIRED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22803775 ↗
• InjuryAug 5, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE CAPSULE FAILED TO ATTACH. IT WAS LOCATED IN THE PATIENT'S ESOPHAGUS AND RETRIEVED VIA SNARE. THE PHYSICIAN VERIFIED THE CAPSULE PLACEMENT ENDOSCOPICALLY. THE DEPLOYMENT DEVICE INSERTED WITH THE CAPSULE FACING THE TONGUE AND WHILE THE ENTIRE DEVICE, INCLUDING THE HANDLE, WAS MAINTAINED IN THE HORIZONTAL PLANE. ANOTHER CAPSULE WAS ATTEMPTED TO PLACE, AND IT WAS SUCCESSFULLY ATTACHED. THE VACUUM PUMP PRESSURE REACHED 550 MMHG PRIOR TO PLACEMENT. NO LUBRICANT WAS USED TO FACILITATE THE PLACEMENT OF THE CAPSULE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22714405 ↗