Z-0400-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 31, 2018
- Initiation Date
- July 14, 2017
- Termination Date
- June 28, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,519,984 enrollments total
Product Description
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
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.
Distribution Pattern
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
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