Proclaim XR 7 Implantable Pulse Generators unable to exit MRI mode
Abbott Medical is recalling Proclaim XR 7 Implantable Pulse Generators due to a malfunction that prevents patients from exiting MRI (Magnetic Resonance Imaging) mode, potentially disrupting normal device operation and therapy delivery.
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: This is an FDA Class I recall, establishing a minimum severity of 4 per the rubric. No deaths or reported injuries are documented, preventing it from reaching the Critical threshold. The device malfunction poses a significant risk of therapy delivery disruption, qualifying this as Severe (4).
Plain-English summary
Abbott Medical is recalling Proclaim XR 7 Implantable Pulse Generators (Model 3662) because patients have reported complaints about being unable to exit MRI (Magnetic Resonance Imaging) mode on their devices. Approximately 41,745 devices have been distributed worldwide, including 32,782 units in the United States.
The FDA classified this as a Class I recall. MRI mode is a protective state designed for use only during MRI procedures. When a device becomes stuck in this mode and cannot be exited, the device may not operate normally or deliver spinal cord stimulation therapy as intended.
Patients with affected serial numbers should contact their healthcare provider immediately if they are unable to exit MRI mode or notice any changes in device operation. Do not attempt to resolve the issue independently. Healthcare providers should review the official FDA recall notice for the complete serial number list and contact Abbott Medical for patient management guidance.
The recalled product
- Product
- Proclaim" XR 7 Implantable Pulse Generator REF 3662 (previously known as Proclaim" 7 Elite IPG) 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 i
- Manufacturer
- Abbott Medical
- Hazard
- device-malfunction
- therapy-delivery-risk
Distribution
Distributed nationwide across the United States.
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