MDT recalls pacing leads on design standards snafu

Medtronic (NYSE:MDT) last month recalled 1 of its temporary pacing leads due to a design standards snafu.

In a June 16 letter to customers who bought the leads, Fridley, Minn.-based Medtronic said its Model 6416 temporary transvenous pacing leads are not compliant with standards set by the FDA and the International Electrotechnical Commission.

The design standards for the leads weren’t written to prevent prevent connecting them to a possibly hazardous voltage, the company said. There have been no reports from customers or on adverse events related to the issue, Medtronic said.

“For patients who have previously received treatment using a Model 6416 lead affected by this recall, no action is necessary as this is an acute use product. Patients who are currently receiving treatment should continue to be managed with your standard patient management protocol and per the product labeling,” the company said in the letter.

Medtronic asked customers to check their inventory for Model 6146 leads and quarantine any they find pending their return to the company.

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