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Open, Classified

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

FDA Recall Z-2226-2023 · Posted 2023-07-21

Recalling FirmMedtronic Neuromodulation
Recall StatusOpen, Classified
Product CodeLGW
Date Initiated2023-06-21
Product Quantity2 clinician tablets

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.

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.

Root Cause

Under Investigation by firm

Distribution Pattern

International distribution to the countries of Israel and Serbia.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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