Class II

Medical Device Recall: Model A710 Intellis Clinician Programmer Application, version 2.0.97

Medtronic Neuromodulation · December 19, 2023

Reason for Recall

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.

Distribution

Germany

Quantity Affected

1 tablet

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0780-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.