# FDA recall Z-1522-2021

> **Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)** · Class II · device recall initiated 2021-04-06.

## Product

CareLink SmartSync Device Manager (24970A).  used to interrogate cardiac implantable electronic devices (CIED).

## Reason for recall

There is a SmartSync software issue that results in an overestimation in the displayed longevity of these devices during an approximate 6-month window of time before the device triggers its Recommended Replacement Time (RRT).

## Distribution

Worldwide

## Key facts

- **Recall number:** Z-1522-2021
- **Recalling firm:** Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-04-06
- **Report date:** 2021-05-12

- **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-1522-2021

## Citation

> AI Analytics. FDA recall Z-1522-2021. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1522-2021. Source: US FDA. Licensed CC0.

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