Bravo FGS-0635Recalls & reported problems
Given Imaging, Inc. · Bravo CF capsule delivery dev, 5-pk · Class 1
All models of Bravo (7)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Bravo capsule delivery device places a capsule in the esophagus. Its 1,582 reports mostly describe the capsule failing to attach to the esophagus or release from the device, and some mention a capsule left in the patient, airway blockage or chest pain. The reports include 355 injuries and no deaths. There are 2 recalls, both open, about capsules that may fail to attach or detach, one linked to misapplied adhesive.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 1,621
- Deaths reported
- 0
- Injuries reported
- 362
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 1,621 adverse event reports that list this exact device (DI 07290101369707), received between Apr 8, 2019 and Sep 29, 2026 — classified as 362 injuries, 1,259 malfunctions.
The most frequently reported specific device problem is “Positioning Failure” (1,152 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.
Reports received per month
Recalls naming this device
- 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 ↗
- 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
Device problems
- Positioning Failure1,152
- Separation Failure323
- Failure to Transmit Record81
- Loss of or Failure to Bond35
- Detachment of Device or Device Component32
- Insufficient Device Problem Information31
- Break23
- Entrapment of Device16
Patient problems
- No Clinical Signs, Symptoms or Conditions771
- Foreign Body In Patient423
- Airway Obstruction285
- No Consequences Or Impact To Patient111
- Insufficient Information27
- Aspiration/Inhalation25
- Hemorrhage/Blood Loss/Bleeding25
- Laceration(s) of Esophagus21
Recent adverse event reports
The 25 most recent of 1,621 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Separation Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933559 ↗MalfunctionSep 24, 2026Positioning Failure
It was reported that the capsule detached from the delivery device but failed to attach to the patient esophagus and was found in the patient stomach. Second capsule was used in the same procedure but failed to attached to esophagus and was found the patient mouth and was retrieved by hand. Third capsule was used in the same procedure but again failed to attached to esophagus and was found in esophagus then pushed to stomach. There was no patient or user harm.
Patient problems: Foreign Body In Patient
MAUDE report 50882676 ↗MalfunctionSep 24, 2026Positioning Failure
It was reported that the capsule detached from the delivery device but failed to attach to the patient esophagus and was found in the patient stomach. Second capsule was used in the same procedure but failed to attached to esophagus and was found the patient mouth and was retrieved by hand. Third capsule was used in the same procedure but again failed to attached to esophagus and was found in esophagus then pushed to stomach. There was no patient or user harm.
Patient problems: Airway Obstruction
MAUDE report 50882583 ↗MalfunctionSep 24, 2026Positioning Failure
It was reported that the capsule detached from the delivery device but failed to attach to the patient esophagus and was found in the patient stomach. Second capsule was used in the same procedure but failed to attached to esophagus and was found the patient mouth and was retrieved by hand. Third capsule was used in the same procedure but again failed to attached to esophagus and was found in esophagus then pushed to stomach. There was no patient or user harm.
Patient problems: Foreign Body In Patient
MAUDE report 50882493 ↗MalfunctionSep 21, 2026Positioning Failure
It was reported that the capsule failed to attach to the patient's esophagus. Another capsule was used in the same procedure and was successfully attached. There was no patient or user harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50840749 ↗MalfunctionSep 21, 2026Separation Failure
It was reported that the capsule failed to detach from the delivery device. The physician broke the handle to release the capsule from the delivery device. The capsule was still attached to the delivery device when it was removed from the patient. There was no patient or user harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50840717 ↗InjurySep 21, 2026Positioning Failure
It was reported that the capsule failed to attach to the patient's esophagus during placement. The capsule was loose in the patient's esophagus and was successfully retrieved using Magill catheter forceps. A second capsule placement was attempted and was successful.
Patient problems: Foreign Body In Patient
MAUDE report 50840259 ↗InjurySep 21, 2026Positioning Failure
It was reported that the capsule failed to attach to the patient's esophagus during placement. The capsule was loose in the patient's mouth and was successfully retrieved using snare. A second capsule placement was attempted and was successful.
Patient problems: Airway Obstruction
MAUDE report 50840192 ↗MalfunctionSep 18, 2026Separation Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829137 ↗MalfunctionSep 18, 2026Positioning Failure
Patient problems: Airway Obstruction
MAUDE report 50829049 ↗InjurySep 18, 2026Positioning Failure
It was reported that the capsule failed to attach to the patient¿s esophagus and was located in front of the esophagus. The capsule was retrieved using forceps or Roth Net. A second capsule placement attempt was performed, and the capsule was successfully attached. Lubricant was used to facilitate the placement of the capsule.
Patient problems: Foreign Body In Patient
MAUDE report 50816596 ↗MalfunctionSep 17, 2026Separation Failure
It was reported that the capsule failed to attach to the esophagus. The capsule remained attached to the delivery device and fell off after removal from the patient. A second capsule placement attempt was performed and was successful. There was no patient or user harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50807269 ↗MalfunctionSep 17, 2026Separation Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50805911 ↗InjurySep 17, 2026Failure to Transmit Record
It was reported that the capsule attached but the recorder started ph of 2. The physician then removed the capsule and placed a second capsule. The short recording was not uploaded. The customer cleared the data and started over with the second capsule.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50805727 ↗MalfunctionSep 17, 2026Separation Failure
It was reported that the capsule failed to attach to the patient's esophagus and remained attached to the delivery device upon removal. They placed a second capsule on the same procedure and still did not attach. The second capsule remained attached to the delivery device upon removal. There was nothing unusual about the patient or procedure. No lubrication was used to facilitate capsule placement. There was no patient or user harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50799755 ↗MalfunctionSep 17, 2026Positioning Failure
It was reported that the capsule detached from the delivery device but failed to attach to the patient's esophagus and was found in the patient's stomach. There was no patient or user harm.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 50799313 ↗InjurySep 17, 2026Difficult or Delayed Separation
It was reported that the patient came in for a follow-up after the study, as there was no confirmed visualization of the capsule passage. The capsule was then retained in the patient¿s esophagus and was successfully removed.
Patient problems: Foreign Body In Patient
MAUDE report 50799274 ↗MalfunctionSep 15, 2026Separation Failure
It was reported that the capsule did not detach from the delivery device. The capsule remained attached to the delivery device when it was removed from the patient. Another capsule was used during the same procedure, but it was unsuccessful. 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 50767654 ↗MalfunctionSep 15, 2026Separation Failure
It was reported that the capsule failed to attach to the patient's esophagus and remained attached to the delivery device upon removal. They placed a second capsule on the same procedure and still did not attach. The second capsule remained attached to the delivery device upon removal. There was nothing unusual about the patient or procedure. No lubrication was used to facilitate capsule placement. There was no patient or user harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50767611 ↗MalfunctionSep 15, 2026Separation Failure
It was reported that the two capsules was failed to attach to the patient's esophagus. The capsule was still attached to the delivery device when it was removed from the patient by using an unknown device Another capsule was used in the same procedure and was successfully attached. There was no patient or user harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50767485 ↗MalfunctionSep 15, 2026Failure to Transmit Record
It was reported that the capsule paired and then lost connection with recorder. There was no patient or user harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50767433 ↗MalfunctionSep 15, 2026Break; Separation Failure
It was reported that during the procedure, doctor tried to deploy the capsule. The trocar needle was deployed but capsule failed to detach from the delivery system and handle came apart but physician did not try and break it. However physician had to remove the capsule and abort the procedure. The capsule was still attached to the delivery device when it was removed from the patient. There was nothing unusual about the procedure. There was no patient or user harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50767044 ↗MalfunctionSep 15, 2026Separation Failure
It was reported that the capsule which failed to attach to the patient¿s esophagus and still attached to the delivery system upon removal. They placed another capsule on the same procedure and still did not attach. Capsule still attach to the delivery system. There was nothing unusual about the patient or the procedure. There was no patient and user harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50766605 ↗MalfunctionSep 15, 2026Separation Failure
It was reported that the capsule which failed to attach to the patient¿s esophagus and still attached to the delivery system upon removal. They placed another capsule on the same procedure and still did not attach. Capsule still attach to the delivery system. There was nothing unusual about the patient or the procedure. There was no patient and user harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50766604 ↗InjurySep 15, 2026Positioning Failure
It was reported that the capsule failed to attach to the patient¿s esophagus and found on the esophagus. Delivery device withdrawn and capsule was retrieve from the esophagus with the device. They placed another capsule on the same procedure and still did not attach. Also retrieve from the esophagus with the device. Third attempt made using capsule from different batch which was instead attempt successful. There was nothing unusual about the patient or the procedure.
Patient problems: Foreign Body In Patient
MAUDE report 50766574 ↗
Other Electrode, pH, stomach devices
- Bravo FGS-0313Given Imaging, Inc. · Electrode, pH, stomach1,103 reports
- Bravo FGS-0636Given Imaging, Inc. · Electrode, Ph, Stomach2 recalls820 reports
- Bravo FGS-0312Given Imaging, Inc. · Electrode, pH, stomach125 reports
- Bravo FGS-0450Given Imaging, Inc. · Electrode, pH, stomach77 reports
- Bravo FGS-0634Given Imaging, Inc. · Electrode, pH, stomach15 reports
- Bravo RFB-0450Given Imaging, Inc. · Electrode, pH, stomach3 reports
- Versaflex 957970Given Imaging, Inc. · Electrode, pH, stomach2 reports
- Digitrapper 800004Given Imaging, Inc. · Electrode, pH, stomach2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- 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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