FDA Amplifies Medtronic Recall of Bravo Acid Reflux Test Capsules After 33 Serious Injuries

Key Insights

• The FDA has amplified a recall of Medtronic's Bravo capsule-based acid reflux testing system following 33 reports of serious injuries related to manufacturing defects.
• The recall stems from misapplied adhesives during manufacturing that can cause capsules to detach from delivery devices or fail to adhere properly to the esophagus wall.
• Potential complications include airway obstruction and tissue perforation leading to internal bleeding, though no deaths have been reported.

The FDA has amplified a recall from Medtronic for its Bravo acid reflux testing system after the company reported 33 serious injuries related to manufacturing defects in the device. The recall affects capsule delivery devices used to diagnose gastroesophageal reflux disease (GERD) through pH monitoring.

Manufacturing Defect Creates Safety Risk

The Bravo capsule-based test involves placing a small pH sensor within the patient's esophagus to detect stomach acid and diagnose GERD cases. According to Medtronic and its Given Imaging subsidiary, the safety issue stems from adhesives that were misapplied during the manufacturing process.

This manufacturing defect can lead to the capsule coming loose from the system's delivery device during the procedure or failing to adhere correctly to the esophagus wall. The FDA warned that these malfunctions can potentially obstruct the patient's airway or perforate tissue, causing internal bleeding.

Recall Response and Patient Safety

Medtronic has confirmed that no deaths have been reported in connection with the device malfunctions. The company, along with its Given Imaging subsidiary, has asked healthcare providers to identify and quarantine all affected devices and return unused items.

The companies sent recall notices to healthcare providers earlier this month, with Medtronic issuing an initial recall letter on June 3 followed by an updated communication on June 16. The notices urge providers to quarantine specific lots of the delivery devices and return them to the manufacturer for replacements or credits.

Device Function and Clinical Use

Bravo capsule delivery devices are designed to place and attach a pH monitoring capsule to a patient's esophagus to record pH data for acid reflux diagnosis. The capsule transmits data to a recorder attached to the patient's waist, providing continuous monitoring capabilities for GERD assessment.

The FDA's amplification of the recall underscores the potential severity of the manufacturing defects and the need for immediate action by healthcare providers using these devices in clinical practice.