# FDA recall Z-2168-2025

> **Medtronic, Inc.** · Class II · device recall initiated 2025-06-18.

## Product

Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components:    1.	Cobalt Crome application, Software Model Number D00U005;    2.	Claria Amplia Compia application, Software Model Number D00U009;    3.	Evera MRI application, Software Model Number D00U010;    3.	Visia AF application, Software Model Number D00U011;    5.	Viva Brava Evera application, Software Model Number D00U012;

## Reason for recall

In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy delivery.

## Distribution

Worldwide - US Nationwide distribution.

## Key facts

- **Recall number:** Z-2168-2025
- **Recalling firm:** Medtronic, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-06-18
- **Report date:** 2025-07-30

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2168-2025

## Citation

> AI Analytics. FDA recall Z-2168-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2168-2025. Source: US FDA. Licensed CC0.

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