Updated to include comment from Medtronic
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.
Medtronic said it discovered that it had incorrectly interpreted an exemption in design standards for the device.
“Medtronic confirms that it has communicated to health care professionals and regulatory authorities that it is recalling all 6416 Temporary Transvenous Active Fixation Pacing Lead Systems that were manufactured after May 1, 2014. The system is disposable, for temporary single patient use, with an intended implant duration of 7 days or less, and is not related to permanent implanted pacemaker systems. Patients with implanted Medtronic pacemakers are not impacted by this recall and need to take no action as a result,” Medtronic wrote in an email to MassDevice.com.
“During an internal review Medtronic discovered that it had incorrectly interpreted an exemption to a regulation requiring the product to comply with certain standards. Medtronic has received no complaints nor are there reports of patient complications related to the issue behind the recall of this temporary device. This action is being taken to prevent the unlikely potential misuse of the 6416 lead,” Medtronic wrote.
There have been no reports from customers or on adverse events related to the issue, the company 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.