# FDA recall Z-1069-2019

> **Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)** · Class III · device recall initiated 2019-03-04.

## Product

Medtronic Pulmonary Vein Ablation Catheter(R) GOLD (PVAC GOLD) 990078 - Product Usage: The Pulmonary Vein Ablation Catheter GOLD is designed to be used for the creation of endocardial lesions (focal and linear) during cardiac ablation procedures for the treatment of symptomatic Atrial Fibrillation (AF). The PVAC GOLD is also intended to be used for cardiac electrophysiological (EP) mapping of pulmonary vein potentials, delivery of diagnostic pacing stimuli and verifying electrical isolation of the pulmonary veins post-treatment.

## Reason for recall

The firm issued an updated instructions for use to reduce the potential for phrenic nerve injury.

## Distribution

International distribution in the countries of Australia, Austria, Brazil, Canada, France, Germany, Hungary, Ireland, Israel, Italy, Latvia, Netherlands, Poland, Portugal, Spain, Switzerland, United Kingdom.

## Key facts

- **Recall number:** Z-1069-2019
- **Recalling firm:** Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- **Classification:** Class III
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-03-04
- **Report date:** 2019-04-03

- **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-1069-2019

## Citation

> AI Analytics. FDA recall Z-1069-2019. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/Z-1069-2019. Source: US FDA. Licensed CC0.

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