Agency classClass IOur severity:Severe FDA (Devices)·Z-2511-2023·Announced 2023-09-20

Infinity 7 Implantable Pulse Generator Recall Due to MRI Mode Exit Failure

Abbott Medical recalls Infinity 7 Implantable Pulse Generators due to reports that patients cannot exit MRI mode. The FDA has classified this as a Class I recall affecting devices distributed worldwide.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA has classified this as a Class I recall, which requires a minimum severity score of 4 per the rubric. Although no deaths, hospitalizations, or injuries are reported in the source, the inability to exit MRI mode on a life-sustaining neuromodulation device represents a significant functional defect requiring immediate attention.

Plain-English summary

Abbott Medical is recalling the Infinity 7 Implantable Pulse Generator (Model 6662), which is designed to deliver electrical stimulation for Deep Brain Stimulation, Spinal Cord Stimulation, and Dorsal Root Ganglion stimulation. A total of 16,395 devices have been distributed worldwide, including 7,793 in the United States and 8,602 internationally.

The firm has received complaints from patients reporting that they are unable to exit MRI (Magnetic Resonance Imaging) mode on their devices. This issue affects the normal operation of the pulse generators during and after MRI procedures.

This is a Class I recall. Patients who have received one of these implants should contact their healthcare provider to discuss their device and any concerns about MRI procedures. Healthcare providers should evaluate patients and may recommend device monitoring or other precautions.

The recalled product

Product: Infinity 7 Implantable Pulse Generator REF 6662 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
Hazard: device-malfunction
mri-mode-failure

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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