# FDA recall Z-0400-2018

> **Medtronic Inc., Cardiac Rhythm and Heart Failure** · Class II · device recall initiated 2017-07-14.

## Product

MyCareLink Smart Patient Monitors.    It is intended for use with a compatible Medtronic patient implanted heart device. The reader is a portable electronic device that communicates with an implanted heart device

## Reason for recall

Patients monitored on two (2) or more implanted Medtronic heart devices in the Medtronic CareLink Network may have potential impact on the ability to remotely monitor the patient's heart devices.  Potential impacts could lead to missed CareAlert notifications or device reports.

## Distribution

Domestic: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA,       Internationally: Austria, Belgium, Brunei, China, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kazakhstan, Latvia, Lithuania, Malaysia, Malta, Netherlands, Norway, Philippines, Poland, Portugal, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, United Kingdom

## Key facts

- **Recall number:** Z-0400-2018
- **Recalling firm:** Medtronic Inc., Cardiac Rhythm and Heart Failure
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-07-14
- **Report date:** 2018-01-31
- **Termination date:** 2024-06-28

- **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-0400-2018

## Citation

> AI Analytics. FDA recall Z-0400-2018. Retrieved 2026-07-02 from https://api.ai-analytics.org/recall/Z-0400-2018. Source: US FDA. Licensed CC0.

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