Early Alert: Esophageal Ph Monitoring Capsule Delivery Device Issue From Medtronic And Given Imaging
Medtronic and Given Imaging is recalling the Bravo CF esophageal pH monitoring capsule because the device may fail to attach to the esophagus or may detach from the delivery device used to place it. This affects patients who have received or are scheduled to receive this capsule for esophageal pH monitoring. When the capsule fails to attach or detaches prematurely, the test cannot measure acid levels as intended.
- Recalling firm
- Medtronic and Given Imaging
- Product
- Esophageal pH Monitoring Capsule Delivery Device
- Reason
- The Medtronic and Given Imaging Bravo CF esophageal pH monitoring capsule can fail to attach to the esophagus or detach from its delivery device.
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-MEDWATCH-RSS
- Recall date
- 2026-08-27
- Status
- Ongoing
Official recall notice from FDA-MEDWATCH-RSS
Recall details on Nibble Recalls: https://trynibble.app/recalls/a9069fad-68bc-4d5e-8640-7c58acb3a766