Recall Z-2117-2017 ยท NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
Medtronic Inc., Cardiac Rhythm and Heart Failure
Amplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan Compia MRI Quad CRT-D SureScan
| Date | Apr 12, 2017 |
| Status | Terminated |
| Reason | An unexpected transient mode switch behavior was detected by Medtronic during systems testing that affects Amplia' "', Claria'"', and Compia'"' Quad CRT-D MRI devices. |
| Root cause | Software design |
| Action | 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 s |
| Quantity | 25,025 ( 16,369 US; 8,656 OUS) |
| Distribution | USA: Nationwide including DC & PR. Worldwide- Distribution : Australia Egypt Ireland Morocco Austria Finland Israel Netherlands Bangladesh France Italy New Zealand Belgium Germany Japan Norway Brunei Darussalam Greece Jordan Oman Canada Guadeloupe Kuwait Poland Cayman Islands Hong Kong Lebanon Po |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.