Medtronic and its subsidiary Given Imaging Inc. have initiated a major recall of certain Bravo CF capsule delivery devices used in esophageal pH monitoring. This recall, classified by the FDA as the most serious type, highlights substantial health risks associated with the device’s malfunction. Clinical, quality, and regulatory teams should take immediate action to ensure compliance and patient safety.
Affected Products and Lot Numbers
The recall involves Bravo CF capsule delivery devices identified by lot numbers FGS-0635 and FGS-0636. These devices are sold in both single-pack (FGS-0636) and five-pack (FGS-0635) formats. Customers must carefully inspect product labels to match affected lot numbers listed in the official recall notices. Specific lot details can be found on the outer label of the five-pack products and on the individual units of the single packs.
What Changed and Why?
On June 3, 2025, Medtronic issued an “URGENT: MEDICAL DEVICE RECALL” letter to all affected users, followed by updated guidance on June 16, 2025. The recall arises due to manufacturing issues where the adhesive application failed to perform as intended during the assembly of the Bravo CF capsules. These failures may prevent the capsules from properly attaching to the esophageal lining or detaching from the delivery device.
The complications linked to these issues include significant risks such as airway obstruction, esophageal perforation, aspiration/inhalation, bleeding, delayed diagnosis, or retention of foreign bodies within the patient. While no deaths have been reported, Medtronic has documented 33 serious injuries related to this problem.
Purpose and Use of the Bravo System
The Bravo system is a diagnostic tool that enables physicians to monitor and measure reflux events in the esophagus. It works by attaching a pH monitoring capsule to the mucosal wall of the esophagus. This capsule records pH levels and transmits data to a wearable recorder. Patients use the recorder to provide symptom feedback, which assists physicians in correlating patient experiences to pH fluctuations, effectively supporting gastroesophageal reflux diagnosis.
Required Actions for Affected Customers
- Immediately identify and quarantine all unused Bravo CF capsule delivery devices from affected lots.
- Return recalled devices to Medtronic for either replacement or credit. Customers must follow the instructions in the Customer Confirmation Form provided in the recall notification.
- Notify all impacted teams, departments, or organizations that may have received or transferred affected products.
Customers are advised to contact Medtronic directly at 800-448-3644, Option 3 for clarification or concerns.
How to Report Adverse Reactions or Quality Issues
Health care professionals and consumers are encouraged to report adverse events or device quality concerns to the FDA through the MedWatch program. This system facilitates accurate tracking and analysis of device defects to improve patient safety and regulatory action speed.
Unique Device Identifier (UDI)
The UDI system helps healthcare providers quickly identify defective devices, enabling faster corrective actions. By tracking devices from manufacturing to patient use, the system focuses on improving reporting accuracy, enhancing safety oversight, and minimizing risks associated with device recalls.
Conclusion: Ensuring Compliance and Safety
This Bravo CF capsule delivery device recall underscores the importance of stringent manufacturing controls and comprehensive risk mitigation strategies. Organizations must act promptly to comply with recall instructions and ensure patient safety. Regulatory teams should review internal processes for ongoing vigilance regarding device-related recalls.
Disclaimer
This information is meant for healthcare professionals and regulatory teams. It does not constitute legal advice. For further actions, refer to relevant FDA and manufacturer guidance documents.
Mandatory FDA Line
For full information about the FDA announcement, see the link below.