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# Reminder on Leadless Pacing System Complications
- URL: https://www.fdaweb.com/reminder-on-leadless-pacing-system-complications/
- Published: 2021-11-18T12:00:00.000Z
- Updated: 2026-09-14T17:22:52.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5150606

FDA is reminding healthcare providers about the risk of major complications if cardiac perforation occurs during leadless pacemaker implantation. An agency [letter](https://www.fda.gov/medical-devices/letters-health-care-providers/leadless-pacing-systems-risk-major-complications-related-cardiac-perforation-during-implantation?ref=fdaweb.com) to providers says the overall risk of cardiac perforation associated with leadless pacemaker implantation appears similar to the risk associated with traditional transvenous pacing systems.

“However,” the letter says, “the Medtronic Micra leadless pacemaker premarket clinical studies suggested major complications related to cardiac perforation appeared to be more severe for patients who received a leadless pacing system compared to patients who received a transvenous pacemaker. FDA continues to evaluate outcomes in patients who receive leadless pacing systems. Information from real-world use suggests that cardiac perforations associated with Micra leadless pacemakers are more likely to be associated with serious complications, such as cardiac tamponade or death, than with traditional pacemakers.”

FDA says it is working with Medtronic to evaluate outcomes after cardiac perforation following implantation of leadless pacemaker systems to identify potential contributing factors and mitigation measures and to ensure the product labeling adequately addresses the issue.