Abbott Infinity 5 Implantable Pulse Generator Patients Unable to Exit MRI Mode
Some Abbott Infinity 5 implantable pulse generator patients report being unable to exit MRI mode on their devices. This Class I recall affects 5,932 devices distributed globally.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification requires a minimum severity score of 4. The inability to exit MRI mode on an implanted neurological device poses a safety concern, though no injuries or deaths have been reported in the source documentation.
Plain-English summary
The Infinity 5 Implantable Pulse Generator (IPG) REF 6660, manufactured by Abbott Medical, is subject to this Class I recall. The device delivers electrical stimulation for spinal cord stimulation (SCS), dorsal root ganglion (DRG) stimulation, or deep brain stimulation (DBS) depending on the model.
The FDA has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their devices. Once in MRI mode, patients report being unable to return their devices to normal operating mode.
The recall affects 5,932 implantable pulse generators: 4,464 distributed in the United States and 1,468 distributed internationally to countries including Canada, Mexico, Australia, Japan, Germany, and the United Kingdom. Specific affected serial numbers are identified by the FDA in the recall documentation.
Patients with affected Infinity 5 IPGs should contact their healthcare provider or Abbott Medical to determine if their device is included in the recall and discuss next steps.
The recalled product
- Product
- Infinity 5 Implantable Pulse Generator REF 6660 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within
- Manufacturer
- Abbott Medical
- Hazard
- mri-mode-malfunction
- device-malfunction
Distribution
Distributed nationwide across the United States.
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