Agency classClass IOur severity:Critical FDA (Devices)·Z-2509-2023·Announced 2023-09-20

Abbott Proclaim DRG Implantable Pulse Generators cannot exit MRI mode

Abbott Medical is recalling approximately 17,394 Proclaim DRG Implantable Pulse Generators worldwide due to reports that patients cannot exit MRI mode on affected devices. This malfunction may prevent normal device operation when mode-switching is needed.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: This is an FDA Class I recall, which by agency classification represents the most serious category of medical device recalls. FDA Class I recalls are issued when there is a reasonable probability that use of the product will cause serious adverse health consequences or death. The confirmed complaints from multiple patients indicate this is not a theoretical hazard.

Plain-English summary

Abbott Medical is recalling Proclaim DRG Implantable Pulse Generator (Model REF 3664) devices distributed worldwide. The recall affects approximately 17,394 units, including 12,134 devices in the United States and 5,260 outside the United States across numerous countries including Canada, Europe, Australia, and others.

The firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their implanted pulse generators. MRI mode is a protective feature for patients with implanted devices, and the inability to exit this mode may compromise the device's normal functioning.

Patients with affected Proclaim DRG devices should contact their healthcare provider immediately to discuss their device status. Healthcare providers should evaluate whether affected devices require reprogramming or replacement to ensure continued safe operation. Patients should not attempt to troubleshoot or adjust their device settings without medical guidance.

The recalled product

Product: Proclaim DRG Implantable Pulse Generator REF 3664 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 is powered by a hermetically sealed battery…
Manufacturer: Abbott Medical
Category: Medical Device — Implantable Pulse Generator / Dorsal Root Ganglion Stimulation
Hazard: device-malfunction
mri-mode-lock

Distribution

Distributed nationwide across the United States.

The notice also names 52 states specifically:

Part of a larger recall action

This product is one of 7 recalled by Abbott Medical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

Same manufacturer · Abbott Medical

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Same hazard · device malfunction