Recall Z-0399-2018— Medtronic Inc., Cardiac Rhythm and Heart Failure
Class II · Terminated
Class II FDA medical device recall by Medtronic Inc., Cardiac Rhythm and Heart Failure, initiated 2017-07-14, terminated 2024-06-28. FDA's recall record names no specific 510(k) clearance for this event. Product: MyCareLink Patient Monitors. It is intended for used with a compatible Medtronic patient implanted heart device. The monitor is an external electronic device that interfaces with Medtronic implanted heart devices and a telecommunications connection to transmit stored implanted heart device data to the physician or clinician.. Reason: 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..
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-07-14
- Terminated
- 2024-06-28
- Firm location
- Mounds View, MN, United States
Product description
MyCareLink Patient Monitors. It is intended for used with a compatible Medtronic patient implanted heart device. The monitor is an external electronic device that interfaces with Medtronic implanted heart devices and a telecommunications connection to transmit stored implanted heart device data to the physician or clinician.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.