Abbott Medical recalls Proclaim Plus 7 Implantable Pulse Generators (REF 3672) due to inability to exit MRI mode, potentially causing safety issues during magnetic resonance imaging procedures.
Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).
Abbott Medical is recalling Proclaim Plus 7 Implantable Pulse Generators (REF 3672) because patients report they cannot exit MRI (Magnetic Resonance Imaging) mode. This could lead to safety risks during MRI scans.
The implantable pulse generator (IPG) is an electronic device used for spinal cord stimulation. Patients report being unable to exit MRI mode, which could cause safety issues during magnetic resonance imaging procedures. This may lead to complications if the device remains in MRI mode when it should be inactive.
Patients with spinal cord stimulation (SCS) implants using the Proclaim Plus 7 Implantable Pulse Generator (REF 3672) are most at risk. The recall affects individuals who have this specific model for spinal cord stimulation.
Check for the model number 3672 on the device. The recall includes Proclaim Plus 7 Implantable Pulse Generators with specific serial numbers listed in the recall notice.
Verify if your device is stuck in MRI mode by attempting to exit the mode through the device's programming interface.
Reach out to Abbott Medical directly for guidance on resolving MRI mode issues with your specific device model.
Abbott Medical has received complaints that patients cannot exit MRI (Magnetic Resonance Imaging) mode on their Proclaim Plus 7 Implantable Pulse Generators.
The recall includes Proclaim Plus 7 Implantable Pulse Generators with model number 3672 and specific serial numbers listed in the official recall notice.
No, the recall does not require immediate discontinuation. Patients should check if their device is stuck in MRI mode and contact Abbott Medical for assistance.
We’ve drafted a message you can send Abbott Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2508-2023 — Abbott Medical Abbott Medical Hello, I own a Abbott Medical that is covered by recall Z-2508-2023 from Abbott Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.