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Medtronic Inc., Cardiac Rhythm and Heart Failure recalls MyCareLink Smart Patient Monitors. It is intended for use with a compatible Medtronic patient implanted heart device.
Recalled January 31, 2018 · FDA recall Z-0400-2018 · Medtronic Inc., Cardiac Rhythm and Heart Failure
Hazard
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 Class II
Units
1,519,984 enrollments total
Sold at
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
Description
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.
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
Manufacturer(s)
Medtronic Inc., Cardiac Rhythm and Heart Failure
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →