Abbott Proclaim Plus 5 Implantable Pulse Generator MRI Mode Exit Failure
Abbott Medical is recalling Proclaim Plus 5 Implantable Pulse Generators (Model 3670) due to reports that patients are unable to exit MRI mode on the devices.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This recall is classified as FDA Class I by the agency, which requires a minimum severity score of 4. Although no specific illnesses or injuries have been reported in the source text, the device malfunction—inability to exit MRI mode—poses a serious risk to patients relying on this critical implantable device.
Plain-English summary
Abbott Medical is recalling certain Proclaim Plus 5 Implantable Pulse Generators (IPGs), Model 3670, serial numbers listed by the manufacturer. These are implantable medical devices used to provide electrical stimulation for treatment of chronic pain, movement disorders, and other neurological conditions.
The firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs. This malfunction prevents the devices from functioning normally after MRI imaging, creating a risk of serious harm to patients.
The FDA has classified this as a Class I recall. Approximately 2,242 devices have been distributed in the United States as of the recall announcement.
The recalled product
- Product
- Proclaim Plus 5 Implantable Pulse Generator REF 3670 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…
- Manufacturer
- Abbott Medical
- Category
- Medical Device
- Affected units
- 2,242
Distribution
Part of a larger recall action
This product is one of 7 recalled by Abbott Medical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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