# FDA recall Z-0771-2025

> **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 CT900B CLINICIAN TABLET EU -UK with the A810 CP app version 2.x, CFN CT900B

## Reason for recall

Software issues were identified in application version 2.x.

## Distribution

Worldwide - US Nationwide distribution.

## Key facts

- **Recall number:** Z-0771-2025
- **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-0771-2025

## Citation

> AI Analytics. FDA recall Z-0771-2025. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0771-2025. Source: US FDA. Licensed CC0.

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