BravoRecalls & reported problems across all models
Given Imaging, Inc. · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Bravo model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3,764
- Deaths reported
- 0
- Injuries reported
- 619
- Recalls
- 2
We found 7 models of Bravo by Given Imaging, Inc. in the FDA's device registry (GUDID). Together they are named in 3,764 adverse event reports in the FDA's MAUDE database, received between Mar 29, 2017 and Sep 29, 2026 — classified as 619 injuries, 3,145 malfunctions.
The most frequently reported specific device problem is “Positioning Failure” (1,933 reports).
2 FDA recall records name at least one of these models by its device 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. 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
Bravo recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Aug 6, 2026Open, 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 · names 2 of these models · Recall details · FDA record ↗
- Jun 3, 2025Open, 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 · names 2 of these models · Recall details · FDA record ↗
Most reported Bravo problems
Device problems
- Positioning Failure1,933
- Loss of or Failure to Bond748
- Separation Failure363
- Failure To Adhere Or Bond260
- Detachment of Device or Device Component181
- Failure to Transmit Record153
- Entrapment of Device75
- Insufficient Device Problem Information66
Patient problems
- No Consequences Or Impact To Patient1,445
- No Clinical Signs, Symptoms or Conditions1,127
- Foreign Body In Patient540
- Airway Obstruction402
- No Known Impact Or Consequence To Patient118
- Aspiration/Inhalation63
- No Information62
- Pain46
Bravo models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Bravo FGS-0635Electrode, pH, stomach2 recalls1,621 reports
- Bravo FGS-0313Electrode, pH, stomach1,103 reports
- Bravo FGS-0636Electrode, Ph, Stomach2 recalls820 reports
- Bravo FGS-0312Electrode, pH, stomach125 reports
- Bravo FGS-0450Electrode, pH, stomach77 reports
- Bravo FGS-0634Electrode, pH, stomach15 reports
- Bravo RFB-0450Electrode, pH, stomach3 reports
Recent Bravo adverse event reports
The 15 most recent reports across all models, 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 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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