# FDA recall Z-2492-2019

> **Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)** · Class II · device recall initiated 2019-08-06.

## Product

Medtronic Micra MC1VR01, Single chamber transcatheter pacing system, REF MC1VR01US (US only).  Cardiac pacemaker.

## Reason for recall

Medtronic is updating the Micra Instructions for Use (IFU) and the Micra Implant Procedure Tip Card to include specific information on the removal of the tether to release the Micra Pacemaker from the Micra Delivery System during implant.

## Distribution

Worldwide

## Key facts

- **Recall number:** Z-2492-2019
- **Recalling firm:** Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-08-06
- **Report date:** 2019-09-18
- **Termination date:** 2023-06-26

- **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-2492-2019

## Citation

> AI Analytics. FDA recall Z-2492-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2492-2019. Source: US FDA. Licensed CC0.

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