FDAFDA · Food and drugs·Recall number Z-0030-2018
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
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: 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 2805627 2805826 2868281 2788539 2871416 2799972 2913205 2874280 2916937 2916955 2913246 2913247 2913224 2913216 2874282 2913208 2913227 2913226 2913255 2913236 2889787 2913232 2928134 2788721 2916947 2916922 2916960 2916965 2916924 2916964 2773081 2913251 2928871 2871413 2872543 2872387 2871415 2917179 2476768 2524636 2520762 2524628 2523935 2520769 2889848 2476736 2524674 2476162 2459127 2458690 2443485 2759489 2759517 2520784 2574279 2874304 2774517 2635736 2574178 2574157 2572326 2524641 2574284 2524673 2574275 2574185 2574168 2366053 2524700 2773037 2572313 2855232 2855632 2872367 2805625 2820119 2820134 2849300 2833622 2859242 2855620 2862593 2862616 2865667 2865707 2870389 2833614 2872384 2865661 2859236 2802267 2865696 2820124 2820138 2796327 2872552 2805885 2840076 2855572 2871414 2872364 2874307 2819450 2874294 2872392 2872372 2872548 2872553 2874277 2872532 2874288 2872366 2874341 2874338 2874285 2874286 2874283 2874301 2872380 2872535 2788735 2872557 2855580 2872542 2872539 2872537 2872379 2872374 2871421 2872375 2872369 2872547 2872386 2872381 2872533 2872365 2441925 2439438 2436001 2435997 2439869 2433894 2433943 2433927 2433910 2433905 2428350 2330880 2441933 2448283 2290520 2294233 2294837 2294849 2287398 2287396 2287530 2287512 2287461 2290611 2432296 2505482 2508737 2333931 2333890 2333857 2333872 2333913 2333870 2333841 2333845 2322974 2448263 2505507 2448278 2499069 2499065 2463794 2463799 2463757 2463949 2463916 2463804 2463864 2448327 2290536 2506677 2790820 2290544 2221752 2221766 2563526 2563563 2616540 2623988 2759520 2759507 2790829 2221767 2788754 2221745 2790844 2790879 2790822 2790819 2788511 2788541 2750579 2728742 2833600 2693696 2693652 2788734 2872391 2728786 2287438 2287404 2278923 2290508 2290527 2290555 2290590 2290586 2290535 2221746 2522652 2290543 2868238 2126012 2135653 2268311 2159295 2179476 2221715 2184502 2159305 2159846 2159821 2448330 2417038 2405131 2418714 2416967 2417062 2416991 2404424 2418763 2408257 2415684 2557486 2808688 2557452 2808711 2663741 2405526 2405505 2405114 2611847 2623980 2624061 2408146 2406891 2406903 2405109 2557465 2588023 2330953 2693695 2762821 2849289 2793080 2788707 2641043 2641035 2641068 2663686 2788715 2663674 2415741 2616559 2833591 2840077 2714908 2762806 2749843 2749846 2780798 2762813 2749845 2582521 2663730 2855569 2333950 2358053 2358006 2354977 2354969 2333859 2333923 2333926 2333958 2333868 2529010 2333894 2358042 2333910 2417120 2354912 2354927 2522653 2520804 2520737 2520694 2515752 2515719 2333869 2330901 2398015 2398026 239
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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