# FDA recall Z-0812-2019

> **Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)** · Class I · device recall initiated 2019-01-17.

## Product

vitatron (implantable pulse generator):    (a) A-series, Model Numbers: A30A1, A60A1  (b) E-series, Model Numbers: E50A1, E60A1  (c) G-series, Model Numbers: G70A1, G70A2  (d) Q-series, Model Numbers: Q50A2, Q70A2, Q80A2

## Reason for recall

A  subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual chamber mode with atrial-sensing, may experience a circuit error that affects device functionality

## Distribution

Wordlwide

## Key facts

- **Recall number:** Z-0812-2019
- **Recalling firm:** Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-01-17
- **Report date:** 2019-02-20

- **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-0812-2019

## Citation

> AI Analytics. FDA recall Z-0812-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0812-2019. Source: US FDA. Licensed CC0.

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