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FDA Warns Of Severe Risks Associated With Medtronic Leadless Pacemakers

Medtronic welcomes agency’s recommendations, highlights device’s safety record

Executive Summary

The US Food and Drug Administration has issued a warning to clinicians of the heightened risk for adverse events, including death, from potential cardiac perforation during implantation of Medtronic’s Micra Transcatheter Pacing System (TPS).

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