Medtronic Recalls OmniaSecure Defibrillation Leads

Medtronic is recalling more than 700 OmniaSecure defibrillation leads due to a risk of implant issues, according to Cardiovascularbusiness. The publication reported that customers are being urged to quarantine and return the affected leads.

The U.S. Food and Drug Administration has classified the action as a Class II recall, Cardiovascularbusiness reported. The publication also stated that no adverse events have been reported.

Recall at a Glance

Cardiovascularbusiness identified the recalled product as the OmniaSecure defibrillation lead. The report said the recall involves more than 700 leads and cited a risk of implant issues.

• Product: OmniaSecure defibrillation leads
• Reported scope: More than 700 leads
• Reason cited: Risk of implant issues
• FDA classification: Class II recall
• Customer action cited: Quarantine and return the leads

Reported Customer Actions

According to Cardiovascularbusiness, Medtronic is urging customers to quarantine and return the affected OmniaSecure leads. The report presents those actions as part of the recall response for the devices.

For medical device sales professionals working with cardiovascular and heart-rhythm accounts, the reported recall information centers on the affected product, the requested quarantine and return actions, and the FDA classification. Account-facing discussions can remain focused on the recall details communicated by Medtronic and reported by Cardiovascularbusiness.

FDA Classification and Adverse-Event Status

Cardiovascularbusiness reported that the FDA ruled the Medtronic action a Class II recall. The publication also reported that no adverse events have been reported in connection with the recall.

The available report does not provide further details beyond the implant-issue risk, the more than 700 recalled leads, the requested quarantine and return actions, the Class II designation, and the reported absence of adverse events.