MASSDEVICE ON CALL — Medical device titan Medtronic (NYSE:MDT) announced late last week that the FDA had put its highest-risk label on a company recall of certain guidewires. The agency deemed the recall a "Class I" issue, reserved for device defects that could "cause serious adverse health consequences or death."
The recall affects a few models of Medtronic’s guidewires, used during percutaneous coronary interventions or the placement of left ventricular leads for cardiac rhythm devices. Medtronic warned that some of its guidewires have surface coatings that can de-laminate and detach, possibly harming the patient.
At least 1 patient injury has been reported, Medtronic said, and a "limited number" of other complaints have also been made. The medical device giant last month began warning customers worldwide, asking healthcare providers to quarantine and immediately return all potentially affected products for credit and replacement.
"Medtronic has also taken the necessary steps to prevent future shipments of the recalled products and notified regulatory agencies around the world as appropriate," according to a company statement.
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