Z-0400-2018Class II

MyCareLink Smart Patient Monitors. It is intended for use with a compatible Medtronic patient implanted heart...

Name: Z-0400-2018 MyCareLink Smart Patient Monitors. It is intended for use with a compatible Medtronic patient implanted heart...
Creator: Medtronic Inc., Cardiac Rhythm and Heart Failure
Published: 2017-07-14
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2017-07-14 / Terminated / root cause: labeling and UDI

FDA source

Medtronic Inc., Cardiac Rhythm and Heart Failure began a recall of MyCareLink Smart Patient Monitors. It is intended for use with a compatible Medtronic patient implanted heart device. The reader is a portable electronic... on 2017-07-14. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0400-2018
Classification: Class II
Status: Terminated
Initiated: 2017-07-14
Posted: 2018-01-19
Terminated: 2024-06-28
Recalling firm: Medtronic, Inc.
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
Product code: NVZ Pulse Generator, Permanent, Implantable
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.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Customers were notified via letter on 07/14/2017. Medtronic communicated that an updated Clinician Instructions for Use has been released with the following updated information: In patients with more than one Medtronic implanted hear device, device data may not be able to transmit from any of the implanted devices to the physician via the Monitor; The patient could potentially transmit device data unintentionally from one of the implanted heart devices when attempting to transmit from another device implanted in the same patient; and a Medtronic Programmer can be used to obtain data from each implanted heart device. Instructions included to ensure all appropriate personnel are notified of this correction.
Quantity in commerce: 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, 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0400-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0399-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-31	2018-01-19
Z-0400-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-31	2018-01-19

Product code NVZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)