FDA Device recall Z-0029-2018
Anthem Model Numbers: PM3210, PM3212
- FDA Device
- Class II
- terminated
- Published 2017-10-25
On 2017-10-25 the FDA classified a Class II recall of Anthem Model Numbers: PM3210, PM3212 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-0029-2018 |
| 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
Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration
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: 7622391 7640623 7638962 7728212 7637541 7693570 7737307 7757416 7637955 7804389 7818448…Serial Numbers: 7622391 7640623 7638962 7728212 7637541 7693570 7737307 7757416 7637955 7804389 7818448 7818627 2928935 3015767 7766148 7604248 7752195 7757623 2845326 2884548 2884290 7765809 7752168 7804384 7675903 7651148 7649402 7511167 7729110 7729097 7639579 2948679 7595363 3002963 7817838 7617597 7650646 7650613 7603335 7694205 2992360 7641322 7636912 7618229 7649382 7649730 7638932 7906629 7650072 7652482 7641324 7641320 7640641 7639577 7638804 7728974 7638929 7638910 7843251 7906501 7817960 7727630 7649374 7650098 7637940 7637400 7637942 7636935 7637376 7636926 7640666 7640648 7727646 7739291 7784767 7727650 7784465 7906198 7906196 7833573 7783933 7817827 7784764 7784456 7847704 7842782 7842694 7784374 7784480 7511329 7784759 7843731 7906186 7728174 7731667 7731878 7783915 7844299 7904089 7842577 7727648 7843149 7842573 7784792 7784468 7784483 7845116 7842742 7683871 |
|---|
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-0029-2018%22
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