# FDA recall Z-0796-2019

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

## Product

MEDTRONIC CARELINK 29901 Programmer for Medtronic and Vitaron Devices

## Reason for recall

The Medtronic CareLink Encore 29901 programmer system is comprised of prescription devices indicated for use in the interrogation and programming of implantable medical devices.   Prior to use, refer to the Programmer Reference Guide as well as the appropriate programmer software and implantable device technical manuals for more information related to specific implantable device models.  Programming should be attempted only by appropriately trained personnel after careful study of the technical manual for the implantable device and after careful determination of appropriate parameter values based on the patient's condition and pacing system used.  The Medtronic CareLink Encore 29901 programmer must be used only for programming implantable devices manufactured by Medtronic or Vitatron.

## Distribution

US, Armenia, Bulgaria, Croatia, Georgia, Hungary, India, Iran, Jordan, Kazakhstan, Latvia, Lebanon, Oman, Pakistan, Qatar, Romania, Saudi Arabia,   Syrian Arab Republic

## Key facts

- **Recall number:** Z-0796-2019
- **Recalling firm:** Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-01-17
- **Report date:** 2019-02-13
- **Termination date:** 2021-02-02

- **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-0796-2019

## Citation

> AI Analytics. FDA recall Z-0796-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0796-2019. Source: US FDA. Licensed CC0.

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