FDAClass IIJanuary 31, 2024

Model A710 Intellis Clinician Programmer Application recall

Model A710 Intellis Clinician Programmer Application, version 2.0.97

Why was Model A710 Intellis Clinician Programmer Application recalled?

Medtronic has discovered an instance in which the Intellis A710 Clinician Programmer Application (CP App) could no longer establish a session with the Implantable Neurostimulator (INS) which resulted in the inability for the clinician to adjust stimulation parameters. In the event of this issue, the patient may receive inadequate or excessive therapy and experience non-optimal pain relief.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI/DI 00763000520076, S/N: NPL1000519

Product
Model A710 Intellis Clinician Programmer Application, version 2.0.97
Recalling firm
Medtronic Neuromodulation
Quantity
1 tablet
Distribution
Germany
Recall date
January 31, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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