The FDA is amplifying a recall from Medtronic for its acid reflux testing system, after the company said it received 33 reports of serious injuries related to the device.
The Bravo capsule-based test includes the placement of a small pH sensor within the patient’s esophagus to help detect stomach acid and diagnose cases of gastroesophageal reflux disease, or GERD.
According to Medtronic and its Given Imaging subsidiary, the issue stems from adhesives that were misapplied during the manufacturing process, which can lead to the capsule coming loose from the system’s delivery device during the procedure or not adhering correctly to the esophagus wall.
The FDA said this can potentially obstruct the patient’s airway or perforate the tissue and cause internal bleeding. Medtronic said no deaths have been reported.
The companies sent a pair of recall notices to healthcare providers earlier this month, urging them to quarantine specific lots of the delivery devices and return them to the manufacturer for replacements or credits.
The agency issued its own notice as part of its pilot program, launched late last year, to accelerate the communication of medical device recalls to the public, describing it as a potentially high-risk issue.