Software Recall: Medtronic Neuromodulation Restore CP App A71100
Announced 2026-06-03 · FDA
The recall covers the Restore Clinician Programmer Application (CP App) software for Model A71100 used with CT900 clinician tablets worldwide. A software issue could display an un-cleared Device Reset message, potentially preventing therapy resumption and causing a recurrence of pain; resolution would require surgical replacement of the implanted device. All software versions prior to v1.0.4489 are affected, and the implanted devices themselves are not affected.
| Brand | Medtronic Neuromodulation |
|---|---|
| Product | Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT900A CLINICIAN TABLET US CT900B PROG CT900B CLINICIAN TABLET EU -UK CT900C PROG CT900C CLINICIAN TABLET UK CT900D PROG CT900D CLINICIAN TABLET GLOBAL CT900E PROG CT900E CLINICIAN TABLET GLBL SMSNG CT900F PROG CT900F CLINICIAN TABLET GLBL SMSNG |
| Reason | 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. |
| Severity | moderate |
| Units affected | 275 |
| 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, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Finland, France, French Polynesia, Germany, Greece, Guatemala, Hong Kong, Hungary, Iceland, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Malta, Mauritius, Mexico, Namibia, Netherlands, New Zealand, Norway, Oman, Panama, Peru, Poland, Portugal, Qatar, Reunion, Russia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay. |
| Agency | FDA |
| Recall / campaign no. | CP App: UDI-DI 00763000273668 all software versions prior to v.1.0.4489 are affected The implanted devices are not affected. |
WHAT YOU SHOULD DO
- Check whether your CP App version is prior to v1.0.4489; if so, contact your clinician or Medtronic support for guidance.
- Consult your healthcare provider to assess whether your implanted device or therapy could be affected and to plan any necessary monitoring.
- Do not attempt self-remediation of the CP App; follow the guidance provided by your clinician or Medtronic.
- Monitor for symptoms such as inability to resume therapy or return of pain, and seek medical attention if they occur.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.