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Getting the latest healthcare news for you
The FDA is warning healthcare providers about 184 serious injuries tied to Medtronic's Bravo calibration-free acid-monitoring capsule delivery device, used to diagnose GERD. The device may fail to properly attach to or detach from the esophagus, risking aspiration, lacerations, perforation, and hemorrhage. Affected lot devices should be quarantined and returned immediately.
The FDA is raising serious concerns about Medtronic's Bravo calibration-free (CF) acid-monitoring capsule delivery device — a tool used to diagnose gastroesophageal reflux disease (GERD) — after linking it to 184 serious injuries. The device works by placing a pH-monitoring capsule against the esophageal wall to record acid levels and transmit data wirelessly to a recorder worn by the patient. A component defect may cause the capsule to fail to attach to the esophagus or detach from the delivery device as intended, particularly if the device isn't held straight during the procedure.
The potential consequences are serious: aspiration, airway obstruction, esophageal laceration or perforation, hemorrhage, and retained device parts. One reported case involved a 28-year-old woman hospitalized in severe pain, with a doctor describing what appeared to be "sloughing off of the entire esophagus" — and she had not been notified of the recall.
By the Numbers:
Why it matters: This is the second recall of the Bravo CF device in roughly a year, raising significant concerns about manufacturing quality control. Clinicians using this device for GERD workups should immediately check lot numbers, quarantine affected units, and ensure patients are informed of potential risks.
