Home / Recalls / Medtronic Inc., Cardiac Rhythm and Heart Failure / Z-0400-2018

Z-0400-2018 Class II Terminated

Recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure — Mounds View, MN

FDA device recall Z-0400-2018 was initiated by Medtronic Inc., Cardiac Rhythm and Heart Failure on July 14, 2017 and is designated Class II. 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. Pot… The recall status is terminated (terminated June 28, 2024). Affected quantity: 1,519,984 enrollments total.

Recall Details

Product Type
Devices
Report Date
January 31, 2018
Initiation Date
July 14, 2017
Termination Date
June 28, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,519,984 enrollments total

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.

Distribution Pattern

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

Code Information

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

Other recalls by Medtronic Inc., Cardiac Rhythm and Heart Failure

  • Z-0399-2018 Class II — MyCareLink Patient Monitors. It is intended for used with a compatible Medtro (July 14, 2017)
  • Z-2117-2017 Class II — Amplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan Compia MRI Quad (April 12, 2017)
  • Z-0962-2017 Class II — Amplia MRI" CRT -D SureScan", Amplia MRI" Quad CRT -D SureScan", Claria MRI" (December 9, 2016)
  • Z-2650-2016 Class II — Medtronic, Viva Quadripolar Implantable Cardioverter Defibrillators: Product (August 12, 2016)
  • Z-2651-2016 Class II — Medtronic, Evera Implantable Cardioverter Defibrillators: Product Model (August 12, 2016)
  • Z-2200-2016 Class II — Medtronic, Temporary Pacing Lead System, Model 6416, Sterile EO. Product Catalo (June 16, 2016)
  • Z-2125-2016 Class II — Medtronic, MyCareLink Patient Monitor, Model 24950, Rx Only. The MyCareLink Mon (May 26, 2016)
  • Z-1605-2016 Class II — Medtronic CareLink" Monitor (2490C) and Medtronic CareLink Express" Monitor (202 (March 31, 2016)

FDA data resources