MyCareLink Smart Patient Monitors — Class II medical device recall Z-0400-2018
Terminated recall by Medtronic Inc., Cardiac Rhythm and Heart Failure, reported 2018-01-31, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Patients monitored on two (2) or more implanted Medtronic heart devices in the Medtronic CareLink Network may
| Recall number | Z-0400-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc., Cardiac Rhythm and Heart Failure, Mounds View, MN, United States |
| Recall initiated | 2017-07-14 |
| Classified | 2018-01-19 |
| Reported by FDA | 2018-01-31 |
| Terminated | 2024-06-28 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA |
| Countries outside the US | AE, AT, BE, CH, CN, CZ, DE, DK, ES, FI, FR, GB, GR, HK, HU, IE, IL, IN, IS, IT, JP, LT, LV, MT, MY, NL, NO, PH, PL, PT, RS, RU, SA, SE, SG, SI, SK, TH, TR, TW, ZA |
| Quantity | 1,519,984 enrollments |
| UPC / GTIN / UDI-DI | 00643169527546, 00643169527553, 00643169527560, 00643169527577, 00643169527584, 00643169527591, 00643169569744, 00643169590397, 00643169666320, 00643169666337, 00643169666344, 00643169666351, 00643169666368, 00643169666375, 00643169666382, 00643169697843, 00643169697850, 00643169742246, 00643169862876, 00643169862883, 00643169947108 |
| Model numbers | 25000 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0400-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.