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Open, Classified

Clinician Programmer Application (CPA) model A610 Clinician Software Application

FDA Recall Z-0201-2022 · Posted None

Recalling FirmMedtronic Neuromodulation
Recall StatusOpen, Classified
Product CodeMHY
Date Initiated2021-09-23
Product Quantity3302

Reason for Recall

A software anomaly may occur with the clinician programmer application.

Firm Action

A customer letter was distributed to impacted customers beginning September 16, 2021. Customers are asked to contact their Medtronic representative or Medtronic Technical Services at 1-800-707-0933 to troubleshoot should they experience the software anomaly issue.

Root Cause

Software design

Distribution Pattern

Worldwide distribution - US Nationwide distribution and the countries of Australia, New Zealand, Canada, Europe, India, Japan, Korea, Middle East, Latin America, Africa, SE Asia and China.

Official Source

View FDA Recall →

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

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