Z-2226-2023Class II

A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application

Name: Z-2226-2023 A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application
Creator: Medtronic Neuromodulation
Published: 2023-06-21
License: https://open.fda.gov/license/

Medtronic Neuromodulation / initiated 2023-06-21 / Open, Classified / root cause: software

FDA source

Medtronic Neuromodulation began a recall of A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application on 2023-06-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2226-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-06-21
Posted: 2023-07-21
Recalling firm: Medtronic Neuromodulation
Product: A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application..
Product code: LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Reason for recall: 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.
Root cause tag: software
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 2 clinician tablets
Distribution: International distribution to the countries of Israel and Serbia.
Product codes and lots: Serial numbers NPL3011706 and NPL3016791, UDI-DI 643169738058.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2226-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2226-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-02	2023-07-21

Product code LGW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)