Amplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan Compia MRI Quad CRT-D SureScan

An unexpected transient mode switch behavior was detected by Medtronic during systems testing that affects Amplia' "', Claria'"', and Compia'"' Quad CRT-D MRI devices.

Medtronic sent an Important Medical Device Information letter dated March 2017. The letter is addressed to Physician or Healthcare Professional. The letter describes the issue and the product involved in the recall. It informs consignees of the upcoming software update and provides directions in Appendix A on how to apply the update to patient devices and to verify that devices are operating correctly.. For questions, contact your local Medtronic Representative or Medtronic Technical Services at 800-723-4636. *Recall has not been initiated in USA only in Japan. UPDATE: Consignees were sent an "Update to Medical Device Correction" letter dated April 2017on 4/26/2017. The letter was addressed to Physicians or Healthcare Professional. The letter informed consignees that the programmer software update is approved for installation. For questions, or if we can be of further assistance, please contact your local Medtronic Representative or Medtronic Technical Services at 800-723-4636. Recall was initiated in USA on 4/26/2017.