Recall Z-0240-2020 ยท OSR Pacemaker/Icd/Crt Non-Implanted Components
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Programmers & Remote Monitoring Software Apps: 29901 CareLink Encore Programmer
| Date | Oct 3, 2019 |
| Status | Open, Classified |
| Reason | There is a potential for Medtronic programmer and remote monitoring software applications to display an inaccurate remaining longevity estimate for a subset of implanted cardiac device models. This issue does not impact device functionality. |
| Root cause | Nonconforming Material/Component |
| Action | In the US, beginning 03-Oct-2019, Medtronic field representatives bean notifying the consignees. A Medical Device Correction Letter will be provided to Follow-up physicians with affected patients. Hospital Risk Managers of accounts that, according to Medtronic records, have affected devices, programmers and remote monitoring systems will receive a courtesy notification. The firm notified the physicians by letter on 10/07/2019 of the issue with the programmer and recommended the following patient management recommendations: Prophylactic device replacement is not recommended, as device fun |
| Quantity | 6713 units |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.