Medtronic recalls capsule delivery devices due to their association with 33 severe injuries
In a significant development, Medtronic's Bravo CF Capsule Delivery Devices have been recalled due to a dangerous manufacturing defect, as announced by the Food and Drug Administration (FDA) in mid-2025 [1][2][4].
The recall, classified as a Class I recall by the FDA, signifies that there is a reasonable probability that the use of these devices could cause serious injury or death [1]. Medtronic has publicly acknowledged the recall and is notifying customers to cease use and return the affected products [2].
The Bravo capsule delivery devices are used to place and attach a pH monitoring capsule to a patient's esophagus. The capsule records pH data, assisting in diagnosing acid reflux. However, the recall is due to product malfunctions that have been linked to 33 serious injuries, including risks such as hemorrhage, laceration of the esophagus, obstruction of the airway, perforation of the esophagus, and foreign bodies remaining in the patient [3].
Interestingly, the recall does not mention any association with patient deaths or any changes in the data transmission process from the capsule to the recorder. It also does not mention any changes in the diagnostic capabilities of the Bravo capsule delivery devices [3].
Official health authorities, including the FDA and other medical regulatory bodies, are primarily focusing on recall management, device quarantine, and return for credit rather than on licensing or resale [4]. As of now, there is no information indicating the availability or the conditions for purchasing or licensing these devices post-recall from Medtronic or the FDA portals [1][2][4].
Given the device's recall status due to critical safety concerns, potential buyers should expect stringent regulatory review and possibly suspension of sales or licensing until Medtronic issues a corrected or new version cleared by the FDA. Without official guidance or public statements from Medtronic regarding purchasing or licensing rights post-recall, no formal procedure is currently documented [1][2][4].
If you require purchasing or licensing options, the recommended approach is to directly contact Medtronic’s regulatory and legal departments or authorized representatives after the recall resolution phase, as current public sources do not provide such guidelines [1][2][4]. It is essential to understand the impact on intellectual property, regulatory clearance, and safety compliance before any such transaction could be approved or recommended.
For the latest updates on the recall, customers are advised to visit the FDA's website or contact Medtronic and its subsidiary Given Imaging directly [1][2]. The Food and Drug Administration published an early alert about the recall on Tuesday [1].
- The Food and Drug Administration (FDA) has announced a recall of Medtronic's Bravo CF Capsule Delivery Devices due to a dangerous manufacturing defect, which is classified as a Class I recall.
- Medtronic is notifying customers to cease use and return the affected devices, following the recall announced by the FDA.
- The Bravo capsule delivery devices are used for placing and attaching a pH monitoring capsule to a patient's esophagus, assisting in diagnosing medical conditions like acid reflux.
- The recall is due to product malfunctions that have been linked to 33 serious injuries, including risks such as hemorrhage and perforation of the esophagus.
- The FDA and other regulatory bodies are primarily focusing on recall management, device quarantine, and return for credit, rather than on licensing or resale.
- Potential buyers should expect stringent regulatory review and possible suspension of sales or licensing until Medtronic issues a corrected or new version of the device, cleared by the FDA.
