>>Policy & Regulation

Class I Recall For Abbott Implantable Pulse Generators

13 Sep 2023

Abbott Medical has recalled several models of its implantable pulse generators (IPGs). The devices are part of the company’s Proclaim neurostimulation systems, which deliver low-intensity electrical impulses to nerve structures.

Sign outside of FDA's headquarters in White Oak, MD — • Source: Alamy

Abbott Medical initiated a recall in July of 155,028 Proclaim and Infinity IPG models distributed in the US from 2015 through 2023 due to complaints from patients who are unable to exit the magnetic resonance imaging (MRI) mode.

The Food and Drug Administration has designated the recall class I, its most serious.