FDAFDA · Food and drugs·Recall number Z-0031-2018
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
Published October 25, 2017 · Recall initiated: August 28, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- St Jude Medical Inc.
- Distributor
- Worldwide Distribution
- Lot
- 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 4586367 4596542 4629057 4586901 4596565 4600219 4600082 4600064 4600706 4588272 4587514 4580702 4619222 4596547 4611578 4620386 4639247 4645279 4665777 4634659 4629018 4645618 4633643 4640711 4620991 4634198 4611532 4620473 4621466 4653223 4609915 4611591 4611560 4667233 4639385 4586354 4618620 4611592 4782618 4764889 4778026 4587483 4588274 4588271 4627257 4586356 4652960 4586371 4726854 4739977 4740047 4580742 4586915 4601236 4639394 4586365 4727890 4727805 4580718 4724051 4724200 4580580 4580789 4596541 4646734 4737883 4603213 4738113 4601936 4602110 4741253 4728277 4738875 4737458 4762401 4737885 4652993 4652211 4649311 4653031 4652983 4614968 4652179 4652204 4652722 4601219 4652501 4580695 4652536 4652680 4650491 4663590 4662182 4663023 4728270 4653260 4652212 4642810 4630327 4665015 4670157 4638685 4641158 4639203 4635313 4782809 4640041 4647802 4639380 4639461 4639035 4640130 4667315 4638719 4633352 4673479 4665315 4611362 4663513 4663619 4622350 4617363 4652694 4618004 4618795 4647285 4636531 4622592 4634171 4653033 4661840 4650863 4652958 4662821 4651547 4652178 4619787 4617933 4650458 4740996 4740675 4724059 4586368 4727452 4580759 4596524 4620474 4650885 4587493 4649505 4622962 4650866 4648997 4782689 4633351 4632129 4683009 4622755 4601591 4644615 4639241 4642911 4646031 4645607 4639033 4640737 4638914 4601089 4737444 4601304 4601564 4601239 4723985 4600201 4727481 4741037 4737497 4647816 4741248 4620486 4663600 4778607 4629977 4669968 4630363 4630335 4669987 4641176 4601271 4643634 4602037 4610191 4647582 4613570 4617940 4623602 4652707 4619826 4647274 4629494 4580705 4621045 4617979 4737495 4737290 4737861 4737336 4601197 4599409 4782518 4602184 4648130 4740302 4580599 4599657 4737296 4741281 4739135 4586703 4601149 4600630 4737493 4782707 4782783 4737304 4602090 4580749 4601610 4580653 4615077 4740286 4601494 4740682 4601603 4741329 4728057 4739754 4614925 4652183 4610856 4740097 4740647 4716844 4709149 4578914 4578849 4714594 4580157 4578897 4717753 4737315 4714818 4737500 4728317 4602864 4580766 4580698 4740662 4738313 4728273 4651934 4713464 4580133 4718529 4714815 4714068 4714179 4714020 4713932 4712968 4614964 4579924 4718027 4580158 4714212 4713952 4713944 4714017 4718669 4713971 4711146 4712950 4647278 4615043 4647572 4647824 4650467 4650285 4661194 4661697 4617920 4714586 4650295 4714839 4661876 4661065 4617387 4647786 4615598 4722398 4714042 4713454 4611593 4580805 4596550 4587484 4600555 4600087 4600093 4601316 4586698 4709088 4727780 4614075 4596569 4601037 4600518 4580613 4596513 4740999 4740952 4737414 4585461 4682686 4614487 4646971 4620344 4619840 4610794 4621050 4610909 4610215 4766409 462
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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