
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.
Check out more MassDevice.com coverage of Medtronic
Zoll launches resuscitation and critical care research foundation
Massachusetts-based Zoll Medical announced the formation of the Zoll Foundation, an independent research and education entity pursuing progress in resuscitation and critical care therapies.
Read more
Medtech outsourcing solutions provider Creganna-Tactx Medical opened its 1st China office in Shanghai, where it hopes to pursue local partnerships and capitalize on the fast-growing Chinese market.
Read more
Healthcare giant Becton Dickinson & Co. (NYSE:BDX) agreed to buy renewable energy credits from Steele Flats Wind Farm for a period of 20 years, purchasing 30 megawatts of electricity for a pair of Nebraska manufacturing plants.
Read more
Medical testing laboratory LabMD, under fire from the Federal Trade Commission after LabMD-generated patient medical records were found online and in the possession of identity thieves, accused the federal agency of orchestrating the breach in order to silence the company’s outspoken CEO.
Read more