FDA Device recall Z-2125-2016
Medtronic, MyCareLink Patient Monitor, Model 24950, Rx Only
- FDA Device
- Class II
- terminated
- Published 2016-07-13
On 2016-07-13 the FDA classified a Class II recall of Medtronic, MyCareLink Patient Monitor, Model 24950, Rx Only by Medtronic Cardiac Rhythm And Heart Failure, citing recently, a new software version was automatically sent to a subset of Model 24950 MyCareLink Monitors. After release, Medtronic identified an issue with the software that prevent….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2125-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-05-26 |
| Published | 2016-07-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medtronic Cardiac Rhythm And Heart Failure |
| Distribution | n/a |
Product
Medtronic, MyCareLink Patient Monitor, Model 24950, Rx Only. The MyCareLink Monitor, Model 24950, is a remote monitoring system that interrogates implanted devices and transmits the data to the Care Link Network for viewing by the physician.
Reason
Recently, a new software version was automatically sent to a subset of Model 24950 MyCareLink Monitors. After release, Medtronic identified an issue with the software that prevents implanted device data from being available to clinicians on the CareLink Network. While the transmission appears successful to the patient, the transmitted data, including CareAlerts, are not visible to the clinic.
Identifiers
| code_info | Serial #'s: YDM001132A YDM091046A YDM230250A YDM287007A YDM316478A YDM338461A YDM001745A YDM092101A YDM230251A YDM2…Serial #'s: YDM001132A YDM091046A YDM230250A YDM287007A YDM316478A YDM338461A YDM001745A YDM092101A YDM230251A YDM287161A YDM319952A YDM338462A YDM002664A YDM096286A YDM230252A YDM287223A YDM320649A YDM338463A YDM002701A YDM100162A YDM230254A YDM287345A YDM320877A YDM338577A YDM003337A YDM102883A YDM230265A YDM287370A YDM321013A YDM339781A YDM004445A YDM102905A YDM231186A YDM287388A YDM321225A YDM339914A YDM004921A YDM110112A YDM231295A YDM287416A YDM334335A YDM340510A YDM005795A YDM127412A YDM231296A YDM287421A YDM335349A YDM340704A YDM010849A YDM127843A YDM234714A YDM287435A YDM335397A YDM358237A YDM010853A YDM128264A YDM240991A YDM289828A YDM335518A YDM359331A YDM011147A YDM141892A YDM241982A YDM289829A YDM335520A YDM359860A YDM011149A YDM144415A YDM242216A YDM291918A YDM335555A YDM362795A YDM011272A YDM150513A YDM242217A YDM291922A YDM336083A YDM363407A YDM012137A YDM150765A YDM252868A YDM291931A YDM336111A YDM366123A YDM013030A YDM150783A YDM253726A YDM292587A YDM336391A YDM |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2125-2016%22
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