FDA Device recall Z-0241-2020
Programmers & Remote Monitoring Software Apps: CareLink SmartSync Device Manager
- 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: CareLink SmartSync Device Manager 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-0241-2020 |
| 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: CareLink SmartSync Device Manager
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: SPM001018A SPM001019A SPM001020A SPM001021A SPM001022A SPM001023A SPM001024A SPM001025A SPM001…Serial Numbers: SPM001018A SPM001019A SPM001020A SPM001021A SPM001022A SPM001023A SPM001024A SPM001025A SPM001026A SPM001027A SPM001028A SPM001029A SPM001030A SPM001031A SPM001032A SPM001033A SPM001034A SPM001035A SPM001036A SPM001037A SPM001038A SPM001039A SPM001040A SPM001041A SPM001042A SPM001043A SPM001044A SPM001045A SPM001046A SPM001047A SPM001078A SPM001079A SPM001080A SPM001081A SPM001082A SPM001083A SPM001084A SPM001085A SPM001086A SPM001087A SPM001092A SPM001093A SPM001094A SPM001096A SPM001097A SPM001098A SPM001100A SPM001101A SPM001102A SPM001103A SPM001105A SPM001106A SPM001107A SPM001108A SPM001109A SPM001110A SPM001111A SPM001112A SPM001113A SPM001114A SPM001117A SPM001118A SPM001119A SPM001120A SPM001121A SPM001122A SPM001123A SPM001124A SPM001125A SPM001128A SPM001130A SPM001131A SPM001132A SPM001133A SPM001134A SPM001136A SPM001137A SPM001138A SPM001139A SPM001140A SPM001141A SPM001142A |
|---|
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-0241-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.