# FDA recall Z-0807-2019

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

## Product

Medtronic implantable pulse generator:  ATTESTA L DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR):   (a) Model Number ATDR01  (b) Model Number ATDRL1  (c) Model Number ATDRS1

## 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-0807-2019
- **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-0807-2019

## Citation

> AI Analytics. FDA recall Z-0807-2019. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/Z-0807-2019. Source: US FDA. Licensed CC0.

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