Medtronic Neuromodulation Model A710 Intellis Clinician Programmer Application, version 2.0.97 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Model A710 Intellis Clinician Programmer Application, version 2.0.97
Brand
Medtronic Neuromodulation
Lot Codes / Batch Numbers
UDI/DI 00763000520076, S/N: NPL1000519
Products Sold
UDI/DI 00763000520076, S/N: NPL1000519
Medtronic Neuromodulation is recalling Model A710 Intellis Clinician Programmer Application, version 2.0.97 due to Medtronic has discovered an instance in which the Intellis A710 Clinician Programmer Application (CP App) could no longer establish a session with the. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
OUS communication to a single German consignee will be initiated via regionally approved methods beginning 19-Dec-2023. A field service technician will go to the site and reset the INS to resolve the issue.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026