# FDA recall Z-0774-2025

> **Medtronic Neuromodulation** · Class II · device recall initiated 2024-11-21.

## Product

SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900E CLINICIAN TABLET GLBL SMSNG and PROG CT900E CLINICIAN TABLET PAPER EN with the A810 CP app version 2.x, CFN CT900E

## Reason for recall

Software issues were identified in application version 2.x.

## Distribution

Worldwide - US Nationwide distribution.

## Key facts

- **Recall number:** Z-0774-2025
- **Recalling firm:** Medtronic Neuromodulation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-11-21
- **Report date:** 2025-01-08

- **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-0774-2025

## Citation

> AI Analytics. FDA recall Z-0774-2025. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0774-2025. Source: US FDA. Licensed CC0.

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