Recall Z-0400-2018
Medtronic Inc., Cardiac Rhythm and Heart Failure · initiated July 14, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: 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
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.
FDA-determined cause: Error in labeling
Action taken
Customers were notified via letter on 07/14/2017. Medtronic communicated that an updated Clinician Instructions for Use has been released with the following updated information: In patients with more than one Medtronic implanted hear device, device data may not be able to transmit from any of the implanted devices to the physician via the Monitor; The patient could potentially transmit device data unintentionally from one of the implanted heart devices when attempting to transmit from another device implanted in the same patient; and a Medtronic Programmer can be used to obtain data from each implanted heart device. Instructions included to ensure all appropriate personnel are notified of this correction.
Details
- Recall number
- Z-0400-2018
- Initiated
- July 14, 2017
- Terminated
- June 28, 2024
- Product code
- NVZ – Pulse Generator, Permanent, Implantable
- Quantity
- 1,519,984 enrollments total
- 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…
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure, Mounds View, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0399-2018 Class II | MyCareLink Patient Monitors. It is intended for used with a compatible Medtronic patient…Patients monitored on two (2) or more implanted Medtronic heart devices in the Medtronic CareLink Network… | 07/14/2017Terminated |