Medtronic MyCareLink Monitors May Miss Heart Device Alerts
Medtronic recalls MyCareLink Smart Patient Monitors used with implanted heart devices. These monitors may miss critical heart device alerts, risking missed CareAlert notifications for patients with two or more implanted devices.
Use caution until it’s fixed
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.
Contact the company
What happened, in plain English
Medtronic is recalling MyCareLink Smart Patient Monitors that connect with implanted heart devices. These monitors could miss important alerts from two or more heart devices, potentially causing dangerous delays in medical care. Read more at govinfonow.com/recall/73411-medtronic-mycarelink-monitors-may-miss-heart-device-alerts.
Source Summary by GovInfoNow · govinfonow.com/recall/73411-medtronic-mycarelink-monitors-may-miss-heart-device-alerts · Updated September 20, 2026 · FDA enforcement record: FDA #Z-0400-2018
Cite this page
“Medtronic MyCareLink Monitors May Miss Heart Device Alerts.” GovInfoNow, updated September 20, 2026. https://govinfonow.com/recall/73411-medtronic-mycarelink-monitors-may-miss-heart-device-alerts. Based on FDA recall #Z-0400-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0400-2018%22&limit=1).
Why it’s dangerous
The monitors may fail to send or receive alerts from two or more implanted heart devices. This could cause missed CareAlert notifications, meaning critical health issues might not be detected until they become serious.
Who’s affected
Patients with two or more Medtronic implanted heart devices who use MyCareLink monitors are most at risk. Owners of these monitors should check if they have the specific model numbers listed in the recall.
How to tell if you have this one
Check for model numbers: 25000, UPN/GTIN codes starting with 00643169527546 through 00643169947108. These monitors are intended for use with Medtronic implanted heart devices.
- Brand
Medtronic- Product
MyCareLink Smart Patient Monitors. It is intended for use with a compatible Medtronic patient implanted heart device- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- 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
| Recall number | Product, codes & lots |
|---|---|
| Z-0399-2018 | 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.; Model (UPN/GTIN): 24950 (00643169292284, 00643169292345, 00643169292260, 00643169292529, 00643169292208, 00643169292192, 00643169292222, 00643169292239, 00643169292321, 00643169292215, 00643169292246, 00643169409132, 00643169292253, 00643169292277, 00643169292291, 00643169292307, 00643169292314, 00643169292338); 24950D (643169467163, 00643169441484, 00643169441101, 00643169367173, 00643169367227, 00643169367159, 00643169409156, 00643169367296, 00643169367302, 00643169367258, 00643169367180, 00643169367166, 00643169367210, 00643169367289, 00643169409149, 00643169367197, 00643169367142, 00643169367241, 00643169367203); 24950D1 (00643169486744); 24950E (00643169493667, 00643169493681, 00643169493698, 00643169493674, 00643169451988, 00643169452015, 00643169452107, 00643169452039, 00643169452121, 00643169452008, 00643169452145, 00643169452046, 00643169452022, 00643169452053, 00643169452138, 00643169452060, 00643169451995, 00643169452114, 00643169452152, 00643169452077, 00643169452084, 00643169452091); 24950F (00643169545274, 00643169552074); 24950G (00643169663039 00643169624337, 00643169599987, 00643169599994, 00643169624368, 00643169624351, 00643169624344, 00643169552104); 24950GLQ (00643169552289, 00643169552050, 00643169552067); 24950J (00643169840591, 00643169658011, 00643169658066, 00643169657892, 00643169658073, 00643169786196, 00643169658059, 00643169658028, 00643169658004, 00643169657908, 00643169657915, 00643169657946, 00643169657953, 00643169657960, 00643169657977, 00643169657984, 00643169657991, 00643169657922, 00643169657939, 00643169658042, 00643169658080, 00643169658097, 00643169657885, 00643169705746, 00643169658035); 24950JLQ (00643169658127, 00643169658134, 00643169658141, 00643169947115, 00643169705753); 24950K (00643169725270, 00643169725324, 00643169725201, 00643169725355, 00643169725331, 00643169725317, 00643169725287, 00643169725263, 00643169725294, 00643169725218, 00643169725232, 00643169725249, 00643169725256, 00643169725225, 00643169725300, 00643169725348, 00643169725195); 24950KLQ (00643169725362, 00643169725379, 00643169725386) |
| Z-0400-2018 | 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; 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 |
What to do — step by step
Check Monitor Model
Identify your monitor's model number or UPN/GTIN code from the list provided in the recall notice.
Contact Medtronic
Reach out to Medtronic directly for guidance on whether your monitor is affected and what steps to take next.
Where it went and when
Where it was distributed
Distributed in 10 states and D.C., and outside the U.S.
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia.
Recall timeline
FDA terminated this recall 7 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0400-2018 (July 14, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0400-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.