The Class 2-level recall involves thousands of devices.
FDA recently issued a Class 2 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 11697 of the Model 6416, with 6174 of the devices in commerce inside the United States. As of May 23, the devices involved in the recall were made after May 1 2014, with expiration dates through April 12, 2018. (A full list of lot numbers is on FDA's website.)
The 6416 temporary transvenous pacing lead is meant for intracardiac pacing and/or EGM recording for up to seven days. The disposable system includes an active fixation, bipolar lead and a soft-tipped, lubricated guide catheter.
The recall was needed because the devices do not comply with design standards meant to prevent connecting a patient's lead to a possible hazardous voltage, according to 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.
Medtronic sent affected customers an Urgent Medical Device Recall letter in June, advising them to identify, quarantine, and return affected products.
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[Graphic of model 6416 courtesy of Medtronic]