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:

• 184 serious injuries linked to the current recall
• 33 serious injuries reported in a prior June 2025 Class I recall of the same device, due to misapplied adhesive during manufacturing
• Lots expiring Dec. 10, 2027 are not affected

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.