FDA Device recall Z-0034-2018
PM1214 NUANCE SR RF
- FDA Device
- Class II
- terminated
- Published 2017-10-25
On 2017-10-25 the FDA classified a Class II recall of PM1214 NUANCE SR RF by St Jude Medical, citing new pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0034-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-08-28 |
| Published | 2017-10-25 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | St Jude Medical |
| Distribution | n/a |
Product
PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
Reason
New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.
Identifiers
| code_info | Serial Numbers: 2678856 2678867 2678859 2678857 2678877 2678872 2678870 2678869 2683929 2678863 2678858 267…Serial Numbers: 2678856 2678867 2678859 2678857 2678877 2678872 2678870 2678869 2683929 2678863 2678858 2678866 2678878 2678868 2678860 2678874 2678879 2678864 2683921 2673458 2683918 2683917 2683914 2683928 2683927 2678862 2683922 2678880 2683920 2683930 2683911 2683916 2675733 2678861 2678871 2683923 2673452 2678876 2675748 2675747 2675742 2675737 2675731 2675743 2673467 2675739 2673449 2673448 2673457 2673459 2673469 2673468 2673466 2673465 2675727 2683924 2678865 2675734 2675728 2675725 2675736 2675745 2675740 2678875 2675732 2675730 2675749 2675746 2675738 2675729 2675735 2675726 2692492 2689903 2691326 2691327 2691328 2691334 2691330 2683919 2689905 2691332 2692495 2692497 2692483 2692488 2692489 2692490 2691329 2689901 2678873 2689899 2689908 2689906 2689907 2689897 2691325 2689900 2691333 2689898 2689909 2689904 2689902 2689896 2691331 2692481 2689910 2686717 2692491 26 |
|---|
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-0034-2018%22
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