Medtronic plc

Rule Changes

Recalling Bravo CF capsule delivery devices; issuing replacements

The Bravo CF device attaches a pH-monitoring capsule to the esophagus so doctors can diagnose acid reflux. In 761 reported instances since early 2025, the capsule failed to attach or detach as intended, and 184 of those involved serious injuries.

Updated Sep 4

New Capabilities

Manufacturer of the OmniaSecure lead; market leader in cardiac rhythm management

For decades, defibrillators have saved lives by shocking dangerously fast rhythms back to normal, but the leads also pace the heart unnaturally and can cause damage over time. Medtronic's OmniaSecure lead is the first defibrillation lead that can pace through the heart's own electrical wiring, closely mimicking natural heartbeats. It has been cleared by the FDA for placement in the left bundle branch area.

Updated May 30

New Capabilities

Developer and manufacturer of INFUSE bone graft

Medtronic's INFUSE bone graft has spent 24 years navigating FDA approval, off-label controversy, and lawsuits. The FDA just approved INFUSE for transforaminal lumbar interbody fusion (TLIF) procedures—the only growth factor bone graft approved for two-level spinal constructs and the only one cleared for anterior, oblique, and transforaminal approaches.

Updated May 29