Recall Z-0962-2017 ยท NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
Medtronic Inc., Cardiac Rhythm and Heart Failure
Amplia MRI" CRT -D SureScan", Amplia MRI" Quad CRT -D SureScan", Claria MRI" CRT -D SureScan", Claria MRI" Quad CRT -D SureScan. implantable medical devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia.
| Date | Dec 9, 2016 |
| Status | Terminated |
| Reason | During internal testing conducted as part of next generation product development, it was discovered that the AdaptivCRT (aCRT) feature of Amplia MRI and Claria MRI CRT -D devices may appear to be enabled when it is not active. |
| Root cause | Software Design Change |
| Action | Consignees were hand delivered beginning on 12/9/2016 a Medtronic "Urgent Medical Device Correction" letter dated December 2016. The letter was addressed to "Dear Physician". The letter described the issue and the product involved in the recall. The letter informed consignees that a software update is being developed to address the issue and it will also address other issue not covered in this recall. The letter also included Appendix A which listed Patient Management Recommendations (Until the software update has been approved and the device models listed in Table A receive the update, f |
| Quantity | 21,111 ( 13,198 US; 7,913 OUS). |
| Distribution | US: All states in USA including DC & PR. OUS: Australia, Finland, Japan, Saudi Arabia, Austria, France, Korea,Singapore, Bangladesh, Germany, Luxembourg, South Africa, Belgium, Greece, Malaysia, Spain, Brunei Darussalam, Guadeloupe, Netherlands, Sweden, Cayman Islands, Hong Kong, New Zealand, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.