Abbott Neurostimulator Recall Deemed Class I by FDA

Abbott Neurostimulator Recall Deemed Class I by FDA

The FDA has classified the Abbott neurostimulator recall as Class I. This is the agency’s most severe classification, reserved for devices that can cause severe injury or even death. Abbott kicked off the recall in June after receiving complaints that patients could not exit the MRI mode. The Proclaim and Infinity neurostimulation systems have been linked to 73 injuries due to the malfunction, stopping much-needed therapy.   

Why Is There an Abbott Neurostimulator Recall? 

Abbott designed the Proclaim and Infinity neurostimulation systems to help those who suffer from chronic pain and movement disorders. These devices offer relief to individuals living with conditions like back pain, leg pain, or those afflicted with pain from prior surgeries. They target specific areas within your body, such as the spinal cord, dorsal root ganglion, and deep brain, delivering the therapy needed to ease that relentless discomfort. 

These devices are designed to be “MRI-safe,” meaning they can usually accompany you during an MRI scan without causing harm. However, they require a special mode that stops stimulation from being activated to ensure safety during the scan. In other words, it temporarily pauses the device until the MRI is over. But once the MRI is done and it’s time to bring your device back to life, some patients find it surprisingly challenging. The implant’s failure to restart places patients at risk of significant harm.  

Abbott Neurostimulator Recall 

The Abbott neurostimulator recall involves approximately 155,028 devices distributed across the United States, manufactured from late 2015 to June 2023. A Bluetooth-paired iPhone or iPod serves as the patient controller device for these neurostimulation systems. It’s the tool that allows patients to control and switch their implants in and out of MRI mode. Think of it as the remote control, enabling patients to make necessary adjustments. 

However, any disruption to this connection can lead to complications. If, for instance, you delete the Bluetooth pairing, lose or disable the controller, or upgrade your iOS software while in MRI mode, it can disrupt the communication between your device and the implant. This disruption means that you may face challenges in restoring your therapy to its normal mode. 

When this occurs, a previously paired clinician programmer is the only one who can restore the therapy. If no previously paired device is available, the patient must undergo surgery to replace the implantable pulse generator to restore therapy.  

FDA Labels Abbott Neurostimulator Recall a Class I 

Abbott, the manufacturer of these neurostimulation systems, has received a total of 186 reports related to this problem, including 73 reports of injuries. Thankfully, there are no deaths tied to the recalled neurostimulators.  

The manufacturer outlined a few recommendations to avoid when preparing for an MRI:  

  • Do not delete the paired Bluetooth connection while you’re in MRI mode. 
  • Download the latest app version on the device before entering MRI mode. 
  • Clinician programmers should maintain connections as a backup. 

The Lake Law Firm will continue to closely monitor the Class I Abbott neurostimulator recall and update this page with any further developments.