Abbott tells The Fly physicians can continue to use Proclaim, Infinity systems

After the FDA posted a recall notice yesterday related to Abbott’s implantable pulse generator that’s used with the company’s Proclaim and Infinity systems, a company spokesman issued the following additional background in a statement issued to The Fly: “Abbott has received reports indicating the loss of Bluetooth connectivity between Abbott’s implantable Proclaim and Infinity systems and its paired patient controller after a patient has undergone an MRI. Based on these occurrences, Abbott previously updated the patient controller Instructions for Use – IFU – and patient controller application MRI-mode screen on smartphones reminding the patient to not delete the paired Bluetooth connection between their Implantable Pulse Generator – IPG – and the patient controller. Abbott has distributed a physician communication to reinforce the importance of following the steps regarding MRI scans outlined in the IFU. The company has communicated this action to physicians and regulatory bodies. No products need to be returned to the company or replaced. Importantly, physicians can continue to use the Proclaim and Infinity systems.”