Recall Z-1523-2021 ยท NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRT-P Quad Models (CRT-Ps): a. Percepta CRT-P MRI: W1TR01, W1TR04, W4TR01, W4TR04 b. Serena CRT-P MRI: W1TR02, W1TR05, W4TR02, W4TR05 c. Solara CRT-P MRI: W1TR03, W1TR06, W4TR03, W4TR06. implantable medical devices used to treat arrhythmias related to bradycardia, and cardiac resynchronization therapy (CRT)
| Date | Apr 6, 2021 |
| Status | Open, Classified |
| Reason | There is a SmartSync software issue that results in an overestimation in the displayed longevity of these devices during an approximate 6-month window of time before the device triggers its Recommended Replacement Time (RRT). |
| Root cause | Software design |
| Action | Beginning 06-APR-2021, Medtronic notified risk managers and practice managers of the field corrective action notification via 2-day UPS delivery of the consignee letter. Confirmation delivery of the consignee letter will be obtained. Medtronic Field Representatives have been instructed to begin installation of the software update. Outside the United States (OUS), communication began on 06- APR-2021 using locally approved methods. Medtronic Field Representatives will begin installation of the software update as it is available locally. Consignees were advised that Medtronic representatives can |
| Quantity | 45,411 devices |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.