MEDTRONIC CARELINK 2090 programmer — Class II medical device recall Z-0795-2019
Terminated recall by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), reported 2019-02-13, distributed in GA. There is an error in how the programmer calculates and displays the remaining longevity value during a period
| Recall number | Z-0795-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), Mounds View, MN, United States |
| Recall initiated | 2019-01-17 |
| Classified | 2019-02-01 |
| Reported by FDA | 2019-02-13 |
| Terminated | 2021-02-02 |
| Distributed | GA |
| Countries outside the US | BG, HR, HU, IN, IR, JO, LB, LV, OM, PK, QA, RO, SA |
| Quantity | 33,007 units |
| UPC / GTIN / UDI-DI | 00061399436092, 00613994127631, 00613994134806, 00613994136480, 00613994136497, 00613994136503, 00613994136510, 00613994136527, 00613994136534, 00613994136541, 00613994136565, 00613994136589, 00613994136596, 00613994136619, 00613994136626, 00613994175076, 00613994175083, 00613994175090, 00613994175106, 00613994175120, 00613994175137, 00613994175144, 00613994175151, 00613994175168, 00613994175175 and 219 more |
| Serial numbers | 00613994136497, 00613994136510, 00613994136527, 00613994136541, 00613994175076, 00613994175083, 00613994175090, 00613994175106, 00613994175120, 00613994175137, 00613994175144, 00613994175151, 00613994175175, 00613994175212, 00613994175236, 00613994175243, 00613994175250, 00613994175267, 00613994175304, 00613994175380, 00613994175397, 00613994175403, 00613994175410, 00613994175588, 00613994175595 and 475 more |
Product
MEDTRONIC CARELINK 2090 programmer
Reason for recall
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0795-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.