The FDA has issued a Class I recall of Abbott Medical's implantable Abbott Proclaim neurostimulation systems, designed to deliver low-intensity electrical impulses to nerve structures for spinal cord stimulation.
The recall affects 155,028 devices distributed between Nov. 21, 2015, and June 29, according to an FDA recall notice initiated by Abbott July 18.
The recall impacts seven Proclaim XR, Proclaim Plus 5, Proclaim Plus 7, Proclaim DRG, Infinity 5 and Infinity 7 models.
A Class I recall is the FDA's most serious recall, with product use potentially leading to serious injury or death. So far, 186 incidents have been reported leading to 73 reported injuries. No deaths have been reported.
The recall was initiated after patients complained of an inability to exit MRI mode. The patient controller (iPhone/iPod) may lose the ability to connect or communicate with the device while in MRI mode.
If there is no previously paired clinician programmer available, or if the clinician programmer lost its Bluetooth connection to the implantable pulse generator, then there is no alternative option to exit MRI mode.
Abbott said in a statement shared with Becker's that no products need to be returned or replaced.
"Based on these occurrences, Abbott previously updated the patient controller instructions for use and patient controller application MRI-mode screen on smartphones reminding the patient to not delete the paired Bluetooth connection between their Implantable Pulse Generator and the patient controller," the statement said. "Abbott has distributed a physician communication to reinforce the importance of following the steps regarding MRI scans outlined in the instructions for use. The company has communicated this action to physicians and regulatory bodies."
Note: This article was updated Sept. 18 to include comment from Abbott.