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Abbott Medical Recalls Proclaim and Infinity IPGs for Inability to Exit Magnetic Resonance Imaging (MRI) Mode

Abbott is recalling its Proclaim and Infinity implantable pulse generators (IPGs) due to complaints from patients who are unable to exit MRI mode. The Patient Controller may lose the ability to connect or communicate with their IPG while in MRI mode. Example situations where this has occurred include when the PC device’s iOS operating system was updated, the PC app was updated or deleted, and when the IPG was deleted from the list of available Bluetooth devices on the PC device.

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Questions?

If you have questions about this recall, contact your local Abbott representative or Abbott Technical Support at 1-800-727-7846 (option 3) for assistance.