Recall Z-0795-2019 ยท OSR Pacemaker/Icd/Crt Non-Implanted Components
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
MEDTRONIC CARELINK 2090 programmer
| Date | Jan 17, 2019 |
| Status | Terminated |
| Reason | There is an error in how the programmer calculates and displays the remaining longevity value during a period of time (up to 2 years) prior to the device reaching its Recommended Replacement Time (RRT). |
| Root cause | Software design |
| Action | In the US, beginning 17-Jan-2019, Medtronic Field Representatives hand delivered a courtesy FCA Notification Letter to consignees who, according to Medtronic records, have programmers that are eligible for Micra software updates. Field Representatives will update the identified programmers using a provided USB. Notification will also be hand delivered to Micra Implanting or Follow-up physicians for awareness of the issue. |
| Quantity | 33007 units |
| Distribution | US, Armenia, Bulgaria, Croatia, Georgia, Hungary, India, Iran, Jordan, Kazakhstan, Latvia, Lebanon, Oman, Pakistan, Qatar, Romania, Saudi Arabia, Syrian Arab Republic |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.