Medtronic Intellis Spinal Cord Stimulator Software Recall
Medtronic is recalling the Intellis Spinal Cord Stimulator software due to a defect that prevents clinicians from programming the implantable neurostimulation device.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a software defect that prevents device programming, which is a functional failure but does not explicitly report injuries, deaths, or high-risk pathogens, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Medtronic Neuromodulation is recalling the Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Programmer application version 1.3.80. The recall involves 7,960 downloads of the software, which was distributed worldwide, including in the United States, Canada, Latin America, Asia Pacific, Japan, China, and European regions.
The recall is being issued because the software contains an issue that can result in the inability to program the Intellis implantable neurostimulation device. This software is intended for use by clinicians to program Medtronic neurostimulators for pain therapy.
Clinicians using this software should be aware that the defect may prevent them from successfully programming the implantable device. No specific instructions for consumers or clinicians are provided in the source text regarding immediate actions to take.
The recalled product
- Product
- Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Programmer application version 1.3.80 - Product Usage: intended for use by clinicians in the programming of the following Medtronic neurostimulators (external and implantable) for pain therapy.
- Manufacturer
- Medtronic Neuromodulation
- Affected units
- 7,960
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Software version 1.3.80
Distribution
Distributed nationwide across the United States.
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