Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported January 31, 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.
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'…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Medtronic Inc., Cardiac Rhythm and Heart Failure recalled MyCareLink Patient Monitors. It is intended for used with a compatible Medtronic patie… - a moderate-severity action.
MyCareLink Patient Monitors. It is intended for used with a compatible Medtronic patie… was recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure in January 31, 2018. Reason: Patients monitored on two (2) or more implanted Medtronic heart devices in the Medtronic CareLink Network may…. Check the official notice for the remedy. Verify recall #Z-0399-2018 with the FDA Devices before acting.
The recall
Medtronic Inc., Cardiac Rhythm and Heart Failure issued this moderate-severity FDA Devices recall-Patients monitored on two (2) or more implanted Medtronic heart devices in the Medtronic CareLink Network may….
- Moderate
- severity level
- Class II
- classification
- January 31, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0399-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0399-2018) was formally reported on January 31, 2018, with the manufacturer initiating the action on July 14, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Medtronic Inc., Cardiac Rhythm and Heart Failure is listed as the recalling firm, operating out of Mounds View, MN. Federal records list the affected scope as 1,519,984 enrollments total.
The documented reason for this recall is: 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 coul… Distribution data in the federal record shows the product reached: 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, Israe…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1,519,984 enrollments total
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0399-2018 |
| Date reported | January 31, 2018 |
| Date initiated | July 14, 2017 |
| Recalling firm | Medtronic Inc., Cardiac Rhythm and Heart Failure |
| Firm location | Mounds View, MN |
| Affected scope | 1,519,984 enrollments total |
| 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, Kaz… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0399-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure. Units affected: 1,519,984 enrollments total.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 31, 2018. Severity: Moderate. Recall number: Z-0399-2018.
Where was the recalled product distributed? ▼
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.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0399-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported January 31, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.