The Food and Drug Administration (FDA) has announced a Class II designation for a recall involving thousands of Medtronic temporary lead pacing systems because there is the potential for them to connect to a hazardous voltage.
The recall involves 11,697 of the model 6416; 6,174 of the devices are in the United States. The remaining devices were distributed to countries worldwide.
The 6416 temporary transvenous pacing lead is meant for intracardiac pacing and/or EGM recording for up to seven days. This is a disposable system that includes an active fixation bipolar lead and a soft-tipped, lubricated guide catheter.
The recall was necessary because the devices do not comply with design standards meant to prevent the lead from being connected to a possibly hazardous voltage, according to the FDA. “The electrical connectors on the leads do not have the proper insulation required by the standard,” Medtronic spokesman Ryan Mathre said in an emailed statement, Qmed reports.
A Class II recall is the FDA’s medium-risk level recall. Class II is for a situation in which use of, or exposure to, the recalled product may cause temporary or medically reversible adverse health consequences. The probability of serious adverse health consequences or death is remote.
The recalled devices were made after May 1 2014, and they have expiration dates that run through April 12, 2018. (A full list of lot numbers can be found on the FDA website.
In June, Medtronic sent an Urgent Medical Device Recall letter to affected customers. The letter was addressed to health care professionals, describing the problem and giving them information about which products are included in the recall. The letter asked health care professionals, medical facilities, and distributors to locate the recalled leads, remove them from inventory, and return them to Medtronic. Customers were instructed to complete a Customer Confirmation Certificate and fax it to Medtronic. Medtronic advised customers to contact their Medtronic sales representative with questions about the recall.