The U.S. Food and Drug Administration (FDA) has announced that Abbott is recalling some of its Proclaim and Infinity neurostimulation systems due to an ongoing issue with patients being unable to exit MRI mode. This is a Class I recall, which means the FDA has determined the use of these devices “may cause serious injuries or death.”
The recall includes more than 155,000 implantable pulse generators (IPGs) used for spinal cord stimulation, dorsal root ganglion or deep brain stimulation. These devices deliver low-intensity electrical impulses to the patient’s nerve structures. They are designed to be temporarily disabled when patients undergo MRI scans through the use of a patient controller (PC) device. However, there have been multiple complaints that the devices are unable to exit this MRI-friendly mode and return to normal use.
“The use of the affected IPGs may require surgery to remove the device and replace it with a new device,” according to the FDA’s advisory.
A total of 186 incidents and 73 patient injuries have been reported due to these issues. There have been no reported deaths.
The IPGs were distributed to customers from November 2015 to June 2023. Specific product names include 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.
Abbott previously alerted customers about this issue back in July with an Urgent Medical Device Correction. The letter, available here in full, includes recommendations for physicians to reduce the risk of IPG replacement surgery. Paired Bluetooth connections between IPGs and PC devices should not be deleted, for example, and PC devices should not be altered in any way while the IPG is in MRI mode. Patients should also ensure their PC devices have been updated to the latest version in their smartphone’s app store.
Abbott emphasized in an emailed statement that this Class I recall did not require all impacted devices to be sent back to the manufacturer.
"No products need to be returned to the company or replaced," according to Abbott. "Importantly, physicians can continue to use the Proclaim and Infinity systems."
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.