Class 2 Device Recall MyCareLink Smart Patient Monitor

• Date Initiated by Firm: July 14, 2017
• Create Date: January 19, 2018
• Recall Status: Terminated on June 28, 2024
• Recall Number: Z-0400-2018
• Recall Event ID: 77964
• PMA Number: P890003
• Product Classification: Pulse generator, permanent, implantable - Product Code NVZ
• 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
• Code Information: 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
• Recalling Firm/ Manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure; 8200 Coral Sea St NE; Mounds View MN 55112-4391
• For Additional Information Contact: Ryan Mathre; 763-514-9625
• Manufacturer 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.
• FDA Determined 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = NVZ