Abbott Medical recalls Infinity 5 Implantable Pulse Generators (REF 6660) that patients may not be able to exit MRI (Magnetic Resonance Imaging) mode. This could cause safety risks during MRI scans. Affected units have specific serial numbers listed in the recall.
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 Infinity 5 Implantable Pulse Generators (REF 6660) because some patients report being unable to exit MRI mode. This could lead to safety issues during MRI scans. The recall includes specific serial numbers listed in the record.
The device may not properly exit MRI mode, which could cause safety risks during MRI scans. This could lead to potential harm if the device interacts with the MRI machine's magnetic fields.
Patients with Infinity 5 Implantable Pulse Generators (REF 6660) used for spinal cord stimulation, dorsal root ganglion stimulation, or deep brain stimulation. Those who have had an MRI scan recently or plan to undergo one are most at risk.
Check if your device has the model number 6660 and the listed serial numbers (e.g., US AAD255.1, AAN997.1, etc.) from the recall notice. The device is used for spinal cord stimulation, dorsal root ganglion, or deep brain stimulation.
Look for the serial number on your device, which should match one of the listed serial numbers (e.g., US AAD255.1, AAN997.1, etc.).
If your device is affected, contact Abbott Medical directly for further instructions on how to address the issue.
The recalled device is the Infinity 5 Implantable Pulse Generator with model number 6660.
No, but you should contact Abbott Medical if your device has a serial number listed in the recall to ensure safety during MRI scans.
The device may not properly exit MRI mode, which could cause safety risks during MRI scans. This could lead to potential harm if the device interacts with the MRI machine's magnetic fields.
We’ve drafted a message you can send Abbott Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2510-2023 — Abbott Medical Abbott Medical Hello, I own a Abbott Medical that is covered by recall Z-2510-2023 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.
