A901 Communication Manager Application, used in conjunction… recallZ-2226-2023 · Medtronic Neuromodulation · initiated Jun 21, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Neuromodulation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-2226-2023
- Status
- Open, Classified
- Initiated by the company
- Jun 21, 2023
- Posted by the FDA
- Jul 21, 2023
- Recalling firm
- Medtronic Neuromodulation
- Quantity
- 2 clinician tablets
- Product code
- LGW
- Distribution
- International distribution to the countries of Israel and Serbia.
Product description
A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application..
Code information (models, lots, serial numbers)
Serial numbers NPL3011706 and NPL3016791, UDI-DI 643169738058.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- N/A A901Medtronic, Inc. · Medical device data system1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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