Medtronic Reflux Device Linked to 184 Serious Injuries, FDA Warns
(MedPage Today) -- The FDA on Thursday warned of 184 serious injuries linked to recalled Bravo calibration-free (CF) acid-monitoring capsule delivery devices, which are used to help diagnose gastroesophageal reflux. "Medtronic stated that the...
The FDA has issued a warning regarding 184 serious injuries associated with a specific model of Medtronic's Bravo calibration-free (CF) acid-monitoring capsule delivery device. Designed to assist in diagnosing gastroesophageal reflux, these devices may not attach to the patient's esophagus or detach properly, posing risks such as aspiration, airway obstruction, and device parts left inside the patient.
The issue appears to stem from a problem with the component controlling the capsule's deployment, exacerbated if the delivery device is not kept straight during the procedure. Medtronic advises against using any devices from the affected lots and recommends they be quarantined for replacement.
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