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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 78093

10 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 28, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
St Jude Medical Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

10 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 10

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

Z-0029-2018
Recall number
Z-0029-2018
Initiated
August 28, 2017
Classification
Class II
Status
Terminated
Recalling firm
St Jude Medical Inc.
Quantity
102684 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.

Code information

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 7641343 7641327 7641341 7640048 7701938 7906621 7637597 7628520 7723706 7728171 7649720 7709817 7693145 7649379 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Distribution pattern

Worldwide Distribution

device · product 2 of 10

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

Z-0030-2018
Recall number
Z-0030-2018
Initiated
August 28, 2017
Classification
Class II
Status
Terminated
Recalling firm
St Jude Medical Inc.
Quantity
529912 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.

Code information

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 2773030 2874302 2721753 2788556 2780339 2832257 2790835 2808759 2788742 2788727 2855223 2788706 2855216 2845835 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Distribution pattern

Worldwide Distribution

device · product 3 of 10

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

Z-0031-2018
Recall number
Z-0031-2018
Initiated
August 28, 2017
Classification
Class II
Status
Terminated
Recalling firm
St Jude Medical Inc.
Quantity
164366 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.

Code information

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 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4663598 4652685 4651689 4652494 4652533 4620424 4616874 4616225 4652709 4650119 4663650 4660374 4661901 4662130 4616239 4619818 4616543 4652185 4652513 4651231 4618025 4615061 4618631 4614505 4623532 4649691 4620492 4652506 4616552 4651524 4611526 4619246 4615085 4621046 4620320 4650903 4652165 4652148 4610792 4609855 4611956 4618785 4623008 4618798 4651917 4611516 4621023 4651914 4615040 4614480 4765771 4762950 4622971 4615630 4662402 4615003 4615060 4620463 4611559 4652207 4647833 4661124 4650477 4650489 4662863 4652532 4652968 4652711 4662412 4653225 4652967 4652701 4652688 4652496 4653026 4653406 4616866 4652692 4652196 4778916 4826537 4618615 4617396 4613575 4611583 4649002 4651692 4652521 4647326 4778042 4646062 4782528 4653405 4652524 4652162 4661552 4653261 4651509 4621496 4663587 4617992 4647777 4648718 4618867 4650883 4611331 4614914 4618873 4611381 4614470 4650500 4663002 4662423 4609661 4615071 4611585 4611348 4617978 4650291 4610915 4621919 4653027 4

Distribution pattern

Worldwide Distribution

device · product 4 of 10

Merlin PCS 3650 Programmer with Model 3330 Software Version 23.1.1 The Merlin Patient Care System (PCS) Model 3650 Programmer is a portable, dedicated programming system designed to interrogate program display data and test St. Jude Medical implantable devices.

Z-0032-2018
Recall number
Z-0032-2018
Initiated
August 28, 2017
Classification
Class II
Status
Terminated
Recalling firm
St Jude Medical Inc.
Quantity
10,453 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.

Code information

Software version 23.1.1

Distribution pattern

Worldwide Distribution

device · product 5 of 10

Merlin@Home Software Model EX2000 v8.2.2 for Merlin@Home Transmitter Models EX1150, EX1150W, EX1100, and EX1100W. The Merlin@home Transmitters are a component of St. Jude Medicals (SJM) Remote Care System. These Merlin@home transmitters are used to retrieve information from the SJM implantable medical device (IMD) using RF telemetry. The data is then sent back to the Merlin.net Patient Care Network through a built-in modem or, alternatively, through a USB cellular adapter or a USB based Broadband Kit. The transmitted data enables clinicians to remotely monitor a patients IMD using a secure, encrypted, password-protected web site, thus reducing the number of in-clinic visits a patient needs to make to their physician. The transmitter monitors the patients device daily between scheduled follow-ups and can alert a clinician if it detects anything out of the norm.

Z-0033-2018
Recall number
Z-0033-2018
Initiated
August 28, 2017
Classification
Class II
Status
Terminated
Recalling firm
St Jude Medical Inc.
Quantity
495,011 units (391,093 in US)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.

Code information

Model EX1100 - GTIN 05414734504782 and Model EX1150 - GTIN 05414734404334

Distribution pattern

Worldwide Distribution

device · product 6 of 10

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.

Z-0034-2018
Recall number
Z-0034-2018
Initiated
August 28, 2017
Classification
Class II
Status
Terminated
Recalling firm
St Jude Medical Inc.
Quantity
2741 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.

Code information

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 2686730 2686728 2686722 2686721 2686726 2686712 2686718 2686723 2686720 2686715 2683913 2683915 2683926 2683912 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2669483 2669512 2669478 2669486 2669492 2669518 2669491 2669496 2669493 2669509 2669508 2669514 2669479 2669533 2669538 2669535 2669519 2669513 2669510 2669506 2669488 2669484 2669481 2669480 2669532 2669489 2669497 2669505 2696338 2696337 2696334 2696333 2696332 2696344 2669537 2696331 2696342 2669516 2669502 2669511 2669507 2669498 2669528 2696343 2700407 2669500 2669525 2700406 2718573 2718567 2700410 2696340 2700408 2696341 2700411 2700413 2700412 2700405 2696336 2696339 2696330 2700409 2669526 2669499 2669501 2669504 2669487 2669476 2669475 2669490 2669534 2669527 2669482 2669523 2669521 2669530 2669529 2669515 2696335 2669495 2669494 2669503 2669520 2669536 2669524 2669522 2669531 2700414 2669485 2669517 2669539 3002748 2718565 2718563 2718562 2821471 2821469 2821468 2821472 2821466 2821467 2941127 3002749 2821470 2941121 2723386 2941130 2941124 2941129 2941125 2941123 3004785 3004784 3050039 3050038 2723388 2276860 2941126

Distribution pattern

Worldwide Distribution

device · product 7 of 10

PM1226 ACCENT ST MRI SR RF and PM2222 ACCENT ST 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.

Z-0035-2018
Recall number
Z-0035-2018
Initiated
August 28, 2017
Classification
Class II
Status
Terminated
Recalling firm
St Jude Medical Inc.
Quantity
101 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.

Code information

Serial Numbers: 2736872 2736871 2736870 2736874 2736873 2538305 2538304 2538301 2538306 2538307 2538302 2512808 2512812 2512811 2384089 2512807 2384108 2384112 2397881 2393253 2393254 2401631 2512803 2401623 2401617 2512810 2384086 2384126 2384101 2384122 2384121 2384105 2384096 2384098 2384116 2384110 2384111 2384120 2384082 2384085 2384123 2384124 2384107 2384117 2384087 2384097 2384077 2393264 2384115 2384119 2384114 2384104 2384100 2384078 2384092 2384081 2384084 2397878 2401620 2384080 2384079 2384099 2401621 2401624 2384083 2512819 2512818 2401626 2401622 2397879 2397872 2393252 2393259 2401619 2401618 2401629 2397874 2397880 2401628 2384106 2393255 2393256 2393257 2512802 2512805 2512800 2512817 2512801 2512804 2512813 2512814 2512815 2512816 2512806 2512809 2384102 2384095 2384125 2384113 2384103 2393262

Distribution pattern

Worldwide Distribution

device · product 8 of 10

PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI 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.

Z-0036-2018
Recall number
Z-0036-2018
Initiated
August 28, 2017
Classification
Class II
Status
Terminated
Recalling firm
St Jude Medical Inc.
Quantity
4828 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.

Code information

Serial Numbers: 4471223 4435620 4471226 4478259 4473923 4465800 4465795 2960123 4471236 4465866 2960119 4480805 4456626 4456605 4456614 4456609 4455665 4470374 2992215 4470251 4478226 2992206 4435532 4436165 4442557 2888746 2992230 4470249 2992219 4481080 4477111 4486603 2992337 4478246 3028382 4470221 2992336 4470256 4470255 4477145 4477154 2992244 4479101 4470215 2817358 2897784 2897779 2897791 2878499 2912102 2912129 2912137 2912163 4427305 2992294 2992270 2992271 2870627 2888748 2912140 2912167 2912110 2912100 4419728 4428451 4495360 4428446 2992205 4479087 4485695 4486629 4486616 4486619 4486415 2992291 2992304 2992208 3028378 2992262 2836144 2992265 2992233 2992331 2992298 2992316 2992225 2992322 2992338 2992221 4480798 2992275 4583284 4507998 4505995 4508010 4540176 4495349 4501470 4510860 4508966 4495359 4535417 4507981 4427067 4508009 4552833 4501456 4505305 4505336 4505325 4505323 4506025 4506017 4507994 4505996 4486592 4568194 4510873 4589129 4548069 4513308 4510893 4450734 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Distribution pattern

Worldwide Distribution

device · product 9 of 10

PM 1260 ASSURITY + 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.

Z-0037-2018
Recall number
Z-0037-2018
Initiated
August 28, 2017
Classification
Class II
Status
Terminated
Recalling firm
St Jude Medical Inc.
Quantity
6051 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.

Code information

Serial Numbers: 4471223 4435620 4471226 4478259 4473923 4465800 4465795 2960123 4471236 4465866 2960119 4480805 4456626 4456605 4456614 4456609 4455665 4470374 2992215 4470251 4478226 2992206 4435532 4436165 4442557 2888746 2992230 4470249 2992219 4481080 4477111 4486603 2992337 4478246 3028382 4470221 2992336 4470256 4470255 4477145 4477154 2992244 4479101 4470215 2817358 2897784 2897779 2897791 2878499 2912102 2912129 2912137 2912163 4427305 2992294 2992270 2992271 2870627 2888748 2912140 2912167 2912110 2912100 4419728 4428451 4495360 4428446 2992205 4479087 4485695 4486629 4486616 4486619 4486415 2992291 2992304 2992208 3028378 2992262 2836144 2992265 2992233 2992331 2992298 2992316 2992225 2992322 2992338 2992221 4480798 2992275 4583284 4507998 4505995 4508010 4540176 4495349 4501470 4510860 4508966 4495359 4535417 4507981 4427067 4508009 4552833 4501456 4505305 4505336 4505325 4505323 4506025 4506017 4507994 4505996 4486592 4568194 4510873 4589129 4548069 4513308 4510893 4450734 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Distribution pattern

Worldwide Distribution

device · product 10 of 10

PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP 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

Z-0038-2018
Recall number
Z-0038-2018
Initiated
August 28, 2017
Classification
Class II
Status
Terminated
Recalling firm
St Jude Medical Inc.
Quantity
2726 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.

Code information

Serial Numbers: 4794381 4913465 4913480 4907866 4909681 4909682 4913495 4909675 4909680 4909677 4909674 4913482 4913489 4913487 4913472 4913458 4913133 4913137 4913477 4909678 4913469 4913459 4913498 4909347 4913492 4913139 4908522 4909679 4909350 4909345 4909348 4909190 4909189 4909188 4909186 4909349 4908662 4909182 4909184 4909183 4909346 4909344 4909185 4909352 4909351 4909187 4913155 4913493 4913844 4913143 4913148 4913166 4913153 4913167 4913163 4913158 4913140 4913466 4913164 4913150 4913125 4913131 4913159 4913162 4913160 4913461 4913146 4913500 4915969 4915951 4915954 4915947 4915958 4915968 4915961 4915949 4913468 4915957 4913842 4913471 4913475 4913481 4913499 4913147 4913496 4913479 4913843 4913132 4915955 4913476 4913152 4913501 4913470 4913462 4913463 4913138 4913134 4913460 4913124 4913473 4913145 4913478 4913464 4913467 4913491 4913483 4913484 4913485 4913486 4913474 4913142 4913127 4913130 4913136 4913129 4913156 4913161 4913488 4913157 4913497 4913141 4913490 4913151 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Distribution pattern

Worldwide Distribution