Abbott recalls neurostimulation implants for Bluetooth bricking flaw

Abbott’s Proclaim XR 5 IPG Model 3660 and the Patient Controller app. (Image from Abbott)

Abbott (NYSE: ABT) + has recalled more than 155,000 implantable pulse generators (IPGs) due to a Bluetooth connectivity flaw that has left some devices unusable.

The Class I recall — the FDA’s most serious level — covers Proclaim and Infinity IPGs used for three kinds of neurostimulation:

 Spinal cord stimulation: Proclaim XR 5 IPG Model 3660 (previously known as the Proclaim 5 Elite IPG Model 3660), Proclaim XR 7 IPG Model 3662 (previously known as the Proclaim 7 Elite IPG Model 3662), Proclaim Plus 5 IPG Model 3670, and Proclaim Plus 7 IPG Model 3672 Dorsal root ganglion stimulation: Proclaim DRG IPG Model 3664 Deep brain stimulation: Infinity 5 IPG Model 6660 and Infinity 7 IPG Model 6662

These devices were distributed in the U.S. between Nov. 21, 2015 and to June 29, 2023. The FDA said 186 incidents and 73 injuri…

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