Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT900A
FDA device recall Z-0996-2026 · posted 2025-12-23 · Open, Classified
Recall details
- Recalling firm
- Medtronic Neuromodulation
- Reason for recall
- Software issue where a Device Reset message displayed on the app was unable to be cleared. In rare cases, this resulted in an inability to resume therapy, and the patient experienced a recurrence of underlying pain symptoms. Resolution would require surgical replacement of the INS.
- Action taken
- On November 20, 2025, the firm notified customers via Urgent Medical Device Safety Notification letters. Medtronic has developed a new version of the A71100 CP App, v1.0.4489 or later, that contains a fix for this issue by ensuring the ability to clear a Device Reset message by pressing OK if the message appears. Customers should download v1.0.4489 or any later version at your earliest convenience.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- LGW
- Quantity affected
- 7667 devices
- Distribution
- Worldwide distribution - US Nationwide and the countries of Argentina, Aruba, Australia, Austria, Belgium, Bosnia And Herzegovina, Brazil, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, C
- Date initiated
- 2025-11-20
- Date posted
- 2025-12-23
- Location
- Minneapolis, MN
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