Abbott Medical recalls Proclaim DRG Implantable Pulse Generators (REF 3664) that patients may not be able to exit MRI mode. This device is used for Dorsal Root Ganglion stimulation. The recall addresses a potential issue with MRI compatibility.
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 DRG Implantable Pulse Generators (REF 3664) because some patients report being unable to exit MRI (Magnetic Resonance Imaging) mode. This device is used for Dorsal Root Ganglion stimulation and may cause issues during MRI scans.
The device may not allow patients to exit MRI mode properly, which could lead to prolonged exposure to MRI magnetic fields. This could cause discomfort or other issues during MRI scans, but does not pose an immediate risk of serious injury.
Patients with Proclaim DRG Implantable Pulse Generators (REF 3664) used for Dorsal Root Ganglion stimulation. Those who have undergone MRI scans recently or plan to undergo MRI scans are most at risk.
Check if your device has the model number 3664 and serial numbers listed in the provided list (e.g., US AAP267.1, AAP380.1, etc.).
Verify your device model number is 3664 and serial numbers match those listed in the recall notice.
Reach out to Abbott Medical for guidance on next steps if your device is affected.
The Proclaim DRG Implantable Pulse Generator (REF 3664) is used for Dorsal Root Ganglion (DRG) stimulation.
Abbott Medical has received complaints that patients are unable to exit MRI mode on their IPGs (Implantable Pulse Generators).
No, but patients who have undergone MRI scans or plan to undergo MRI scans should contact Abbott Medical for guidance.
We’ve drafted a message you can send Abbott Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2509-2023 — Abbott Medical Abbott Medical Hello, I own a Abbott Medical that is covered by recall Z-2509-2023 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.
