FDA Device recall Z-0400-2018
MyCareLink Smart Patient Monitors
- FDA Device
- Class II
- terminated
- Published 2018-01-31
On 2018-01-31 the FDA classified a Class II recall of MyCareLink Smart Patient Monitors by Medtronic Cardiac Rhythm And Heart Failure, citing 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'….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0400-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-07-14 |
| Published | 2018-01-31 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medtronic Cardiac Rhythm And Heart Failure |
| Distribution | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA |
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
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.
Identifiers
| code_info | Model 25000, UPN/GTIN 00643169527546, 00643169569744, 00643169666337, 00643169697843¿, 00643169862876, 00643169697850,…Model 25000, UPN/GTIN 00643169527546, 00643169569744, 00643169666337, 00643169697843¿, 00643169862876, 00643169697850, 00643169742246, 00643169862883, 00643169666375, 00643169666382, 00643169666344, 00643169666351, 00643169666368, 00643169666320, 00643169590397, 00643169527584, 00643169527591, 00643169527553, 00643169527560, 00643169527577, 00643169947108 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0400-2018%22
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