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美敦力Bravo CF胶囊输送装置成为FDA早期警报的焦点
2026-08-28 00:04
- The US FDA has issued an Early Alert for related to Medtronic (MDT)-owned Given Imaging's Bravo CF esophageal pH monitoring capsule delivery devices.
- The agency said that some capsules "may not attach to the patient’s esophagus or detach from the delivery device as intended." This can result in patient aspiration/inhalation, esophageal perforation, obstruction of the airway, hemorrhage/blood loss/bleeding, laceration of the esophagus, a delay in diagnosis, and foreign bodies staying in the body.
- While no deaths have been reported, Medtronic has reported 184 serious injuries as of Aug. 10
- Medtronic has informed customers that impacted Bravo CF devices should not be used or sold.
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