Abbott Medical recalls Proclaim" XR 7 Implantable Pulse Generators (REF 3662) due to patients being unable to exit MRI mode. This device is used for spinal cord stimulation and may require specific actions to ensure safe MRI use.
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" XR 7 Implantable Pulse Generators with model number 3662 because patients have reported being unable to exit MRI (Magnetic Resonance Imaging) mode. This could lead to safety issues during MRI scans if the device remains active.
The device's inability to exit MRI mode during scans can cause safety risks if the patient remains in the MRI field. This may prevent the patient from safely completing the MRI procedure or lead to unintended device activation during the scan.
Patients using spinal cord stimulation devices with this specific model (Proclaim" XR 7 Implantable Pulse Generator REF 3662) are most at risk. The issue affects those who need to undergo MRI scans without being able to safely exit the MRI mode.
Check for the model number 3662 on the device. This product was previously known as Proclaim" 7 Elite IPG and is used for spinal cord stimulation. The recall includes specific serial numbers and UDI-DI codes listed in the official notice.
Verify if your device is stuck in MRI mode by attempting to exit the mode through the device's interface.
Reach out to Abbott Medical for guidance on safely exiting MRI mode or alternative solutions.
Abbott Medical has received complaints from patients who are unable to exit MRI mode on their Proclaim" XR 7 Implantable Pulse Generators (REF 3662).
Patients with this device may not be able to safely exit MRI mode during scans, which could lead to safety issues if the device remains active in the MRI field.
Contact Abbott Medical to check if your device is stuck in MRI mode and follow their guidance for safe exit procedures.
We’ve drafted a message you can send Abbott Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2506-2023 — Abbott Medical Abbott Medical Hello, I own a Abbott Medical that is covered by recall Z-2506-2023 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
