Medtronic Balances a Class I Recall Against Fresh Pipeline Wins and a Looming MiniMed Deadline
Article excerpt
Medtronic is navigating one of the more awkward stretches of its recent history: a top-severity safety action on an esophageal monitoring device, a string of regulatory clearances across its heart and vascular franchises, and a spinoff exchange offer that is now weeks away from expiring. The stock finished Friday at EUR 76.72, down 0.3% on the day, giving the medical technology group a market value of EUR 97.94 billion. On September 15, the U.S. Food and Drug Administration classified the recall of Medtronic's Bravo CF capsule delivery system - run together with subsidiary Given Imaging - as a Class I recall, the agency's most serious designation. According to the FDA, use of the affected products can lead to severe injury or death. As of August 10, 2026, 184 serious injuries had been reported in connection with the system. No fatalities have been linked to it, the agency said. The device, used to monitor pH levels in the esophagus, is being withdrawn from the market under the FDA's supervision. While the recall plays out, Medtronic's pipeline has been collecting wins. The FDA granted breakthrough device status to the company's IN.PACT BTK drug-coated balloon on September 30. To build out the clinical case, Medtronic plans a global randomized pivotal trial enrolling roughly 400 patients. The device is designed to treat vascular disease below the knee and remains in...
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Medtronic also earned a place on Fortune's 2026 "Change the World" list, recognized for its Touch Surgery surgical ecosystem and its Healthy Neighbor initiative.