FDA Device recall Z-0795-2019
MEDTRONIC CARELINK 2090 programmer
- FDA Device
- Class II
- terminated
- Published 2019-02-13
On 2019-02-13 the FDA classified a Class II recall of MEDTRONIC CARELINK 2090 programmer by Medtronic Cardiac Rhythm And Heart Failure Crhf, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0795-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-01-17 |
| Published | 2019-02-13 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Medtronic Cardiac Rhythm And Heart Failure Crhf |
| Distribution | GA |
Product
MEDTRONIC CARELINK 2090 programmer
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).
Identifiers
| code_info | UPN Lot Serial # 00613994175397 PKK005256R 00721902246241 PKK005435R 00613994175380 PKK010235R 00613994136541…UPN Lot Serial # 00613994175397 PKK005256R 00721902246241 PKK005435R 00613994175380 PKK010235R 00613994136541 PKK010864R 00613994175106 PKK010944R 00613994175106 PKK013390R 00613994175076 PKK014053R 00721902171079 PKK014459R 00721902246241 PKK016196R 00613994581594 PKK019007R 00613994175397 PKK053072R 00613994175397 PKK053799R 00885074314921 PKK100200R 00885074301440 PKK100970R 00885074312873 PKK101320R 00885074312866 PKK101390R 00885074312873 PKK101826R 00613994175144 PKK102639R 00885074313122 PKK104915R 00613994175250 PKK106350R 00613994434982 PKK200802R 00613994435309 PKK200982R 00613994435309 PKK201102R 00613994434937 PKK203476R 00613994434937 PKK203505R 00613994580894 PKK204058R 00613994580962 PKK204433R 00613994580887 PKK205733R 00613994580924 PKK205784R 00613994580894 PKK206708R 00613994580962 PKK206741R 00613994580962 PKK206743R 00613994581532 PKK210147R 00613994581532 PKK210150R 00613994581532 PKK210151R 00613994581532 PKK210155R 0061 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0795-2019%22
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