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
Check against the official notice below — it lists the full affected range.
Medtronic is recalling MyCareLink Smart Patient Monitors (Model 25000) used to remotely monitor patients with two or more implanted Medtronic heart devices connected to the Medtronic CareLink Network. The issue is that the monitors may not properly track patients with multiple devices, potentially causing missed alert notifications or device reports. The recall affects approximately 1.5 million enrollments distributed across multiple U.S. states and countries internationally.
The recall document does not specify a remedy or recommended course of action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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: 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 Afr Quantity: 1,519,984 enrollments total Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.