FDA Device recall Z-0031-2018
Assurity MRI Model Numbers: PM1272, PM2272 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indi…
- FDA Device
- Class II
- terminated
- Published 2017-10-25
On 2017-10-25 the FDA classified a Class II recall of Assurity MRI Model Numbers: PM1272, PM2272 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indi… 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-0031-2018 |
| 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 MRI Model Numbers: PM1272, PM2272 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: 4614099 4596216 4596638 4727863 4611510 4614078 4611861 4611876 4635855 4616825 4728102 4…Serial Numbers: 4614099 4596216 4596638 4727863 4611510 4614078 4611861 4611876 4635855 4616825 4728102 4619514 4611919 4621031 4621034 4620372 4620495 4618816 4778046 4647279 4739147 4652154 4611355 4611962 4781006 4782745 4762369 4580750 4580699 4727919 4737221 4727846 4740088 4740697 4736769 4740335 4727012 4727917 4738401 4641014 4580684 4617156 4621413 4648598 4647009 4662138 4621077 4652686 4652526 4645582 4621012 4617402 4647544 4611377 4617938 4782292 4782687 4762387 4782229 4737273 4647864 4726629 4634656 4629019 4740653 4726989 4739143 4601150 4727010 4727803 4614087 4596511 4650941 4740363 4737514 4580630 4580765 4739963 4580806 4738879 4647284 4728018 4639005 4635760 4644659 4629592 4665627 4679417 4641180 4638907 4617405 4639221 4600690 4638206 4670070 4639034 4646675 4624054 4624121 4650482 4646990 4639228 4601060 4610758 4611562 4782767 4782661 4765479 4765426 |
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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-0031-2018%22
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