Medtronic’s Bravo capsule delivery devices have caused 33 serious injuries, prompting an urgent FDA recall that raises alarming questions about medical device manufacturing oversight.
Key Takeaways
- Medtronic has recalled multiple lots of Bravo CF Capsule Delivery Devices following 33 documented serious injuries related to device malfunctions
- The recall stems from a manufacturing defect involving misapplied adhesive that can cause the capsule to detach improperly or not attach to the esophagus
- Patients face potentially life-threatening risks including aspiration, esophageal perforation, airway obstruction, and hemorrhage
- Healthcare providers have been instructed to quarantine and return all affected devices from specific lot numbers for replacement or credit
FDA Issues High-Risk Alert for Defective Medical Devices
The Food and Drug Administration has taken decisive action against potentially dangerous medical devices by issuing an early alert regarding Medtronic’s Bravo CF Capsule Delivery Devices. The alert comes after the documentation of 33 serious patient injuries directly linked to malfunctions in these diagnostic tools commonly used for monitoring gastroesophageal reflux disease. This represents yet another instance of regulatory intervention required to protect Americans from faulty medical technology that somehow made it through quality control processes at major manufacturers.
“Medtronic has recalled Bravo capsule delivery devices due to product malfunctions that have been tied to 33 serious injuries, an early alert published Tuesday by the Food and Drug Administration,” according to the FDA.
The recall specifically targets devices with model number FGS-0635 and lot numbers 62143F, 62880F, 63146F, and 63397F. Medtronic and its subsidiary Given Imaging Inc. have taken the extraordinary step of recommending the complete removal of these products from both use and commercial availability. The timing of this recall raises questions about how long patients were potentially exposed to these hazardous devices before action was finally taken by regulatory authorities.
Manufacturing Defect Creates Serious Patient Hazards
At the heart of this recall is a critical manufacturing error involving the improper application of adhesive during production. This seemingly simple mistake has led to potentially catastrophic consequences for patients. The defect can cause the pH monitoring capsule to either fail to properly attach to the esophagus during placement or to detach prematurely from the delivery device. In either scenario, patients face substantial risks including aspiration of the loose capsule, perforation of the esophagus, airway obstruction, and even severe hemorrhage.
“URGENT: MEDICAL DEVICE RECALL,” according to Medtronic.
The Bravo system plays an important role in diagnosing gastroesophageal reflux by placing a small monitoring capsule on the esophageal wall to transmit pH data to a recorder worn by the patient. When functioning properly, this technology provides valuable diagnostic information without major intervention. However, the manufacturing defects have transformed these helpful tools into potentially life-threatening objects that can break free and cause severe internal damage to unsuspecting patients undergoing what should be routine diagnostic procedures.
Urgent Customer Response Required
On June 3, 2025, Medtronic sent an urgent recall notice to affected customers, followed by an update on June 16, 2025. Healthcare providers have been instructed to immediately identify, quarantine, and return all affected devices to Medtronic for either replacement or credit. This rapid removal of potentially dangerous products from circulation represents a necessary but disruptive interruption to medical practices that rely on these diagnostic tools for patient care. The impact on patients awaiting diagnostic procedures may result in delays for proper treatment.
Customers with questions or who need to report adverse reactions can contact Medtronic directly at 800-448-3644, Option 3. Additionally, healthcare professionals and consumers are encouraged to report any issues to MedWatch, the FDA Safety Information and Adverse Event Reporting Program. “This incident underscores the critical importance of robust quality control processes and post-market surveillance of medical devices to prevent unnecessary harm to American patients seeking routine medical care through established healthcare channels,” according to the FDA.
