Medtronic recalls defibrillation leads due to risk of implant issues

Medtronic is recalling certain OmniaSecure defibrillation leads due to an increased risk of implant issues. No adverse events have been reported, but clinicians did report experiencing difficulties that could potentially lead to “tissue trauma.” 

The U.S. Food and Drug Administration (FDA) has ruled that this is a Class II recall, which means using the devices “may cause temporary or medically reversible adverse health consequences.”

Medtronic initiated the recall in September, notifying customers that they should “quarantine and return” any affected OmniaSecure defibrillation leads.

“Medtronic recently requested the retrieval of a subset of nonimplanted OmniaSecure defibrillation leads for an engineering evaluation,” a company spokesperson told Cardiovascular Business. “The notification request for retrieval was limited to a subset of leads that may have undergone a specific manufacturing sequence as identified by an internal quality process. There have been no reports of patient harm.”

This recall covers more than 700 OmniaSecure defibrillation leads distributed throughout the United States. The two item numbers are 3930M74 or 3930M79. Only the leads specifically included in this recall are being recalled. Click here for a list serial numbers.

Medtronic emphasized that this Class II recall does not affect any devices that have already been implanted. 

“Patient safety remains Medtronic's highest priority,” according to the company’s statement to Cardiovascular Business. “Medtronic is taking proactive steps to further evaluate these leads and support healthcare providers in ensuring the continued safe and effective use of its products.”

Click here for more from the FDA.