MyCareLink Patient Monitors — Class II medical device recall Z-0399-2018
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-0399-2018 |
|---|---|
| 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 | 00643169292192, 00643169292208, 00643169292215, 00643169292222, 00643169292239, 00643169292246, 00643169292253, 00643169292260, 00643169292277, 00643169292284, 00643169292291, 00643169292307, 00643169292314, 00643169292321, 00643169292338, 00643169292345, 00643169292529, 00643169367142, 00643169367159, 00643169367166, 00643169367173, 00643169367180, 00643169367197, 00643169367203, 00643169367210 and 98 more |
| Model numbers | 00643169292192, 00643169292208, 00643169292215, 00643169292222, 00643169292239, 00643169292246, 00643169292253, 00643169292260, 00643169292277, 00643169292291, 00643169292307, 00643169292314, 00643169292321, 00643169292345, 00643169292529, 00643169367142, 00643169367159, 00643169367166, 00643169367173, 00643169367180, 00643169367197, 00643169367210, 00643169367227, 00643169367241, 00643169367258 and 88 more |
Product
MyCareLink Patient Monitors. It is intended for used with a compatible Medtronic patient implanted heart device. The monitor is an external electronic device that interfaces with Medtronic implanted heart devices and a telecommunications connection to transmit stored implanted heart device data to the physician or clinician.
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-0399-2018. 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.