Abbott Medical has recalled certain Proclaim and Infinity neurostimulation systems after 73 people were injured.
The recall involves about 155,000 implantable pulse generators (IPGs). These devices deliver low-intensity electrical shocks to stimulate the brain, spinal cord, or dorsal root ganglion.
IPGs are sometimes implanted in patients with Parkinson’s disease and other movement disorders.
The devices are supposed to be turned off when patients undergo MRI scans, but there were many reports of the devices being unable to exit the MRI mode and return to normal use.
When this occurs, patients “may require surgery to remove the device and replace it with a new device,” according to the FDA.
There were 186 reported incidents, including 73 patients who were injured due to these issues.
No deaths were reported, but surgery to replace the device poses life-threatening risks, especially for patients with underlying health issues like Parkinson’s disease, according to the FDA.
The recall involves the Proclaim XR 5 IPG, Proclaim XR 7 IPG, Proclaim Plus 5 IPG, Proclaim Plus 7 IPG, Proclaim DRG IPG, Infinity 5 IPG and Infinity 7 IPG.
These devices were distributed distributed from November 2015 through June 2023. The recall began in July 2023 when Abbott sent doctors an “Urgent Medical Device Correction” letter.
In September 2023, the FDA upgraded the recall to a Class 1 recall, which is the most serious type of recall, reserved for devices that can cause serious injuries or death.