FDA Device recall Z-0030-2018
Assurity Model Numbers: PM1240, PM2240
- FDA Device
- Class II
- terminated
- Published 2017-10-25
On 2017-10-25 the FDA classified a Class II recall of Assurity Model Numbers: PM1240, PM2240 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-0030-2018 |
| 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
Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Numbers: PM1210, PM2210, PM1222, PM2212; Accent MRI Model Numbers: PM1224, PM2218, PM2224 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: 2759491 2712645 2721539 2780831 2712625 2717492 2717871 2736600 2717397 2714912 2768520 2…Serial Numbers: 2759491 2712645 2721539 2780831 2712625 2717492 2717871 2736600 2717397 2714912 2768520 2721733 2721752 2712653 2762819 2736601 2736644 2780837 2780832 2717477 2740357 2740399 2717872 2717878 2714878 2736611 2736639 2736649 2717400 2721570 2740394 2717500 2805600 2712642 2840094 2859254 2799954 2799945 3067828 2805829 2953350 2805840 2859262 2808720 2862603 2790810 2820148 2862599 2953185 2953376 2721748 2762847 2762833 2762836 2872389 2953390 2749844 2953394 2953349 2953182 2953366 2953329 2955340 2773029 2728721 2721768 2799983 2762812 2774498 2774483 2832212 2762754 2721573 2780829 2780824 2780805 2780785 2740375 2768559 2762861 2855201 2762781 2762807 2780770 2762856 2736630 2794367 2832272 2871419 2833615 2862614 2872529 2805612 2855206 2794638 2721749 2780792 2832963 2832989 2855217 2790826 2717515 2762759 2773014 2855202 2727395 2727382 2736646 2762850 |
|---|
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-0030-2018%22
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