Medtronic Neuromodulation A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application.. 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
A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application..
Brand
Medtronic Neuromodulation
Lot Codes / Batch Numbers
Serial numbers NPL3011706 and NPL3016791, UDI-DI 643169738058.
Products Sold
Serial numbers NPL3011706 and NPL3016791, UDI-DI 643169738058.
Medtronic Neuromodulation is recalling A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer appli due to When an update to the A710 Clinician Programmer software application for the Intellis Neurostimulation System was released, the corresponding version . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
When an update to the A710 Clinician Programmer software application for the Intellis Neurostimulation System was released, the corresponding version of the A901 Communication Manager software application was not available for download.
Recommended Action
Per FDA guidance
Only one of the two consignees received the notification since one of the consignees independently updated their tablet. On 6/22/2023, the notification dated June 2023 was issued to the consignee via visit by the sales representative. The notification described the issue and provided required actions which included: (1) Update the A901 Comm Manager application to version 1.0.1239 on the clinician programmer (tablet), serial #NPL3011706, using the instructions listed in Appendix A, Updating Clinician Programmer Software; (2) Complete the Customer Confirmation Form enclosed with the letter acknowledging that the consignee has received this information; and (3) Share this notice with all those who need to be aware of the issue within the organization and maintain a copy of it in the records.
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