FDAFDA · Food and drugs·Recall number Z-0780-2024
Model A710 Intellis Clinician Programmer Application, version 2.0.97
Published January 31, 2024 · Recall initiated: December 19, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Neuromodulation
- Distributor
- Germany
- Lot
- UDI/DI 00763000520076, S/N: NPL1000519
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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