Recall Z-0400-2018— 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 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: 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 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.