FDA Device recall Z-0239-2020
Programmers & Remote Monitoring Software Apps: 2090 CareLink Programmer
- FDA Device
- Class II
- ongoing
- Published 2019-11-06
On 2019-11-06 the FDA classified a Class II recall of Programmers & Remote Monitoring Software Apps: 2090 CareLink Programmer by Medtronic Cardiac Rhythm And Heart Failure Crhf, citing 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 d….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0239-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-10-03 |
| Published | 2019-11-06 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Medtronic Cardiac Rhythm And Heart Failure Crhf |
| Distribution | n/a |
Product
Programmers & Remote Monitoring Software Apps: 2090 CareLink Programmer
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.
Identifiers
| code_info | Serial Numbers: PKK051331R PKK200187R PKK209956R PKK207572R PKK209265R PKK016592R PKK202460R PKK019811R PKK20…Serial Numbers: PKK051331R PKK200187R PKK209956R PKK207572R PKK209265R PKK016592R PKK202460R PKK019811R PKK209256R PKK007753R PKK015981R PKK016604R PKK017955R PKK018301R PKK019555R PKK019776R PKK051452R PKK052792R PKK204491R PKK204504R PKK204551R PKK204575R PKK204595R PKK204640R PKK204740R PKK203409R PKK006360R PKK202461R PKK018408R PKK019864R PKK204483R PKK016046R PKK016047R PKK019820R PKK020201R PKK010563R PKK209937R PKK209928R PKK050581R PKK209305R PKK211241R PKK209294R PKK201567R PKK206687R PKK211282R PKK208961R PKK209373R PKK202996R PKK210858R PKK202566R PKK211233R PKK205628R PKK209203R PKK211710R PKK100124R PKK211042R PKK210807R PKK200224R PKK208864R PKK209197R PKK208958R PKK209332R PKK211720R PKK016352R PKK019371R PKK211286R PKK202507R PKK205997R PKK205974R PKK202465R PKK017835R PKK018895R PKK201637R PKK201640R PKK201643R PKK201645R PKK202394R PKK202397R PKK202411R PKK202428R PKK202441R PKK202444R |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0239-2020%22
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