# FDA recall Z-0996-2026

> **Medtronic Neuromodulation** · Class II · device recall initiated 2025-11-20.

## 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 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.

## 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.

## Key facts

- **Recall number:** Z-0996-2026
- **Recalling firm:** Medtronic Neuromodulation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-11-20
- **Report date:** 2025-12-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Minneapolis, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0996-2026

## Citation

> AI Analytics. FDA recall Z-0996-2026. Retrieved 2026-09-09 from https://api.ai-analytics.org/recall/Z-0996-2026. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*