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.
