Medtronic Restore Clinician Programmer software recalled for compatibility issue
Medtronic is recalling Restore Clinician Programmer Application Software due to compatibility issues with legacy software that prevent communication with implanted neurostimulators. The recall affects 2,408 devices worldwide.
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: This is a Class II FDA recall for a voluntary, precautionary software update addressing a technical compatibility issue. No illnesses or injuries have been reported, and the hazard is functional rather than directly harmful.
Plain-English summary
Medtronic Neuromodulation is recalling version 1.0.4232 of the Restore Clinician Programmer Application Software (model A71100). The software has a compatibility issue with some legacy clinician programmer software, resulting in the programmer's inability to establish communication with implanted neurostimulators.
This recall affects approximately 2,408 devices distributed worldwide, including the United States (with government and military distribution), Australia, and Singapore.
Affected customers should contact Medtronic Neuromodulation to obtain software updates or instructions on addressing the compatibility issue. Patients with implanted neurostimulators should consult with their healthcare provider if they have concerns about their device.
The recalled product
- Product
- Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.
- Manufacturer
- Medtronic Neuromodulation
- Affected units
- 2,408
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 (2)
- Version 1.0.4232
- UDI-DI 00763000273668.
Distribution
Distributed nationwide across the United States.
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