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U.S. Department of Health and Human Services

Class 2 Device Recall SQRX

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 Class 2 Recall
SQRX
see related information
Date Posted March 18, 2013
Recall Status1 Terminated on May 23, 2013
Recall Number Z-0965-2013
Recall Event ID 64546
Premarket Approval
PMA Number
P110042
Product Classification Implantable Cardioverter Defibrillator (Non-Crt) - Product Code LWS
Product Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.
Code Information SERIAL NUMBERS A002804 A003105 A001493 A001784 A001981 A003024 A003197 A001609 A001594 A001733 A002291 A002348 A002373 A002195 A002710 A004131 A001942 A002278 A002399 A002402 A001021 A001136 A001104 A001193 A001392 A002093 A002147 A001134 A001155 A001063 A001011 A001102 A001012 A001004 A001058 A001010 A001140 A001093 A001170 A001055 A001185 A001144 A001217 A001215 A001241 A001367 A001377 A001405 A001431 A001380 A001468 A001411 A001639 A001688 A001734 A001578 A001654 A001799 A001916 A001903 A002127 A002076 A002425 A002686 297-899 300-895 292-887 A001120 A001085 A001109 A001089 A001122 A001110 A001020 A001052 A001023 A001051 A001062 A001148 A001042 A001106 A001091 A001096 A001126 A001237 A001341 A001354 A001447 A001429 A001533 A001481 A001236 A001119 A001246 A001384 A001267 A001731 A001650 A001774 A001856 A001980 A001752 A002364 A002823 A002826 A002833 A002858 A002889 A002892 A002946 A002997 A002996 A002953 A003386 A003465 A003066 A003382 A003426 A003540 A003563 A001291 A001463 A002985 A001146 A001174 A001040 A001005 A001053 A001180 A001195 A001194 A001188 A001233 A001270 A001273 A001197 A001294 A001368 A001338 A001332 A001152 A001423 A001344 A001443 A001235 A001317 A001363 A001512 A001513 A001538 A001489 A001480 A001334 A001500 A001820 A001680 A001647 A001652 A001630 A001696 A001789 A001740 A001781 A001271 A001711 A001661 A001573 A001772 A001636 A001682 A001750 A001437 A001882 A002050 A002036 A002045 A001910 A002015 A001888 A002068 A001605 A002005 A001860 A002234 A002300 A002337 A002087 A002295 A002272 A002141 A002261 A002243 A001958 A002266 A002014 A002071 A001768 A002158 A002286 A002403 A002194 A002228 A002292 A002418 A002252 A002342 A002459 A002374 A002424 A002485 A002276 A002523 A002027 A002376 A002672 A002645 A002267 A002553 A002608 A002737 A002999 A003124 A003138 A003285 A003449 A004002 A003886 A003694 A003842 A001732 A001660 A001800 A001427 A001418 A001428 A001441 A001454 A001635 A001566 A001697 A001653 A001634 A001811 A001623 A001837 A001793 A001745 A001905 A001863 A001867 A001887 A001588 A001808 A001953 A001859 A001690 A001729 A001692 A001872 A001871 A001908 A001822 A002013 A001550 A002083 A001932 A001952 A001923 A002095 A001832 A002134 A002135 A001824 A002003 A001875 A001987 A001853 A001850 A001817 A001975 A001739 A002082 A002111 A002017 A001896 A001843 A002165 A001920 A001990 A001695 A001962 A002102 A002339 A001801 A002113 A002136 A002084 A002235 A002105 A002150 A002143 A002118 A002022 A002204 A002211 A002069 A001963 A001970 A001861 A002210 A002397 A001847 A002101 A002131 A002157 A001960 A002232 A002098 A002103 A001985 A001629 A002175 A001792 A002160 A002249 A002250 A002199 A002188 A002289 A002318 A002400 A002110 A002242 A002254 A002213 A002312 A002223 A001921 A002224 A002393 A002077 A002075 A002315 A002361 A001993 A002251 A002226 A002420 A002156 A002245 A002125 A001876 A002177 A002370 A002241 A002230 A001865 A002427 A001597 A002416 A001753 A002338 A002369 A002454 A001727 A002349 A002423 A002326 A002203 A002434 A002458 A002461 A002382 A002407 A002336 A002575 A002323 A002537 A002499 A002139 A002356 A002367 A002438 A002383 A002448 A002457 A002647 A001787 A002311 A002408 A002661 A002529 A001880 A002255 A002554 A002299 A002595 A002366 A002006 A002675 A002462 A002325 A002592 A002653 A002507 A002616 A002472 A002107 A002428 A002117 A002603 A002715 A002572 A002587 A002417 A002586 A002598 A002582 A002535 A002629 A002617 A002518 A002599 A002649 A002638 A002679 A002631 A002431 A002774 A002779 A002551 A002716 A002557 A002628 A002640 A002687 A002803 A002677 A002761 A002786 A002784 A002674 A002696 A002639 A002741 A002789 A002814 A002727 A002048 A002820 A002708 A002765 A002806 A002464 A002702 A002526 A002749 A002422 A002513 A002790 A002319 A002651 A002565 A002759 A002530 A002656 A002775 A002746 A002704 A002813 A004236 A003020 A003030 A003019 A003023 A003628 A003635 A003918 A003921 A003791 A003835 A003922 A003937 A003923 A003725 A003931 A003942 A003934 A003945 A003927 A004067 A003968 A003939 A003935 A003833 A003960 A003977 A003965 A003936 A003943 A003980 A003970 A004076 A003933 A003938 A004021 A003975 A003920 A003917 A003689 A003712 A003841 A003944 A004051 A003852 A003951 A003949 A003947 A003974 A004055 A003900 A003950 A003954 A003948 A004061 A004089 A004080 A004127 A004073 A004039 A003930 A003667 A003696 A004033 A004099 A003877 A004143 A004163 A004164 A004063 A004072 A004139 A003849 A004040 A004098 A004225 A004074 A004235 A003953 A004119 A003928 A003957 A004011 A004133 A003956 A004065 A004151 A004204 A004100 A004038 A004050 A004031 A004138 A004181 A004199 A004215 A004239 A004060 A004107 A004226 A004105 A004137 A004128 A004150 A004249 A004256 A003871 A003631 A004064 A004140 A003978 A004198 A003630 A004185 A004222 A004233 A004224 A004266 A004268 A004290 A004345 A004296 A004308 A004190 A004221 A004261 A004269 A003926 A004208 A004142 A004246 A004267 A004350 A003962 A004159 A004192 A003633 A003959 A004071 A003952 A004217 A004218 A004030 A004244 A004253 A004289 A004053 A004242 A004118 A004191 A004045 A004240 A004348 A004329 A004044 A004149 A004264 A004288 A004262 A004212 A004303 A004025 A004077 A004561 A003982 A004213 A004356 A004435 A004447 A004464 A004508 A003961 A004101 A004171 A004366 A004295 A004361 A004369 A004452 A004518 A004086 A004515 A004391 A004405 A003916 A004183 A004272 A004453 A003964 A004404 A004514 A004306 A004327 A004384 A004487 A004512 A004546 A003958 A004507 A004534 A004559 A004382 A004419 A004494 A004501 A004506 A004548 A004624 A004588 A004284 A004682 A003643 A004450 A004479 A004172 A004461 A004444 A004451 A004531 A004618 A004738 A004374 A004357 A004161 A004394 A004488 A004389 A004406 A004554 A004547 A004596 A004616 A004093 A004344 A004544 A004549 A004569 A004049 A004573 A004545 A004539 A004586 A004611 A004625 A004711 A004397 A004455 A004509 A004731 A004407 A004591 A004697 A004517 A004576 A004395 A004587 A004562 A004583 A004600 A004277 A004568 A004420 A004552 A004619 A004707 A004694 A001131 A001216 A001414 A001440 A002054 A002975 A003053 A003147 A003260 A003189 A003362 A003451 A004176 A004462 A003618 A004387 A004684 A001022 A001160 A001015 A001014 A001154 A001142 A001159 A001124 A001107 A001181 A001175 A001196 A001199 A001212 A001370 A001315 A001345 A001312 A001356 A001228 A001203 A001289 A001307 A001285 A001223 A001230 A001278 A001264 A001218 A001245 A001311 A001330 A001358 A001424 A001420 A001526 A001305 A001382 A001508 A001525 A001406 A001316 A001352 A001419 A001438 A001509 A001395 A001379 A001510 A001462 A001490 A001499 A001506 A001310 A001648 A001210 A001340 A001664 A001821 A001642 A001775 A001686 A001704 A001726 A001780 A001707 A001744 A001794 A001904 A001879 A001559 A001716 A001624 A001699 A001894 A002037 A001891 A002078 A001870 A001912 A001211 A001866 A001925 A001396 A001665 A001836 A001840 A001926 A001846 A001893 A001979 A001746 A001546 A001873 A002018 A001616 A001622 A001592 A001598 A002001 A002010 A001693 A001645 A001657 A001700 A001806 A001599 A001791 A001796 A002038 A001549 A002002 A001927 A001991 A001583 A002043 A002073 A002106 A001760 A001988 A001897 A001918 A002094 A002128 A002166 A002067 A002186 A002191 A002154 A002169 A002104 A002028 A001842 A002332 A002116 A002317 A001408 A001679 A001934 A002146 A001826 A001900 A002341 A001884 A002057 A002350 A002189 A002347 A002026 A002109 A002033 A002132 A002065 A001881 A002298 A001885 A002011 A002279 A002284 A001869 A002096 A002253 A002259 A002120 A002307 A002173 A001999 A002044 A002088 A001997 A002263 A002152 A002246 A001839 A002159 A002222 A002378 A002138 A002379 A002392 A002035 A002281 A002217 A002353 A002398 A002396 A002309 A001989 A001855 A002357 A002360 A002368 A002227 A002024 A002371 A001977 A002268 A002460 A002488 A002389 A002452 A002233 A002409 A002421 A002385 A002258 A002446 A002456 A002273 A002490 A002229 A002351 A002007 A002432 A002257 A002477 A002142 A001759 A002270 A002486 A002576 A002346 A002129 A002377 A002437 A002481 A002294 A002288 A002355 A002509 A002282 A002264 A002494 A002549 A002697 A002614 A002495 A002633 A002637 A002491 A002666 A002429 A002471 A002506 A002144 A002426 A002504 A002384 A002706 A002489 A002345 A002521 A002654 A002545 A002600 A002062 A002673 A002728 A002755 A002605 A002601 A002680 A002632 A002285 A002671 A002731 A002650 A002660 A002752 A002602 A002711 A002590 A002754 A002683 A002777 A002238 A002581 A002713 A002644 A002768 A002668 A002730 A002469 A002501 A002729 A002736 A002670 A002463 A002795 A002475 A002483 A002498 A002643 A002776 A002484 A002520 A002522 A002555 A002531 A002735 A002620 A002534 A002624 A002750 A002556 A002547 A002550 A002564 A002800 A002515 A002798 A002692 A002567 A002560 A002542 A002331 A002517 A002301 A002511 A002703 A002740 A002748 A002607 A002724 A002802 A002505 A002540 A002588 A002619 A002766 A002597 A002527 A002676 A002589 A002825 A002433 A002751 A002866 A002479 A002778 A002830 A002583 A002594 A002856 A002883 A002745 A002758 A002613 A002859 A002837 A002718 A002634 A002838 A002714 A002695 A002611 A002627 A002404 A002641 A002871 A002842 A002839 A002851 A002652 A002760 A002805 A002788 A002688 A002684 A002852 A002888 A002849 A002328 A002698 A002831 A002843 A002876 A002925 A002895 A002922 A002939 A002705 A002904 A002873 A002967 A002862 A002609 A002894 A002891 A002682 A002903 A002669 A002890 A002832 A002867 A002909 A002932 A002874 A002841 A002923 A002963 A002850 A002717 A002915 A002960 A002964 A002966 A002927 A002869 A002870 A002905 A002694 A002945 A002937 A002954 A002901 A002940 A002799 A002861 A002899 A002919 A002993 A002987 A002926 A002947 A002984 A002579 A002935 A002914 A002976 A002921 A002965 A002878 A003000 A003021 A002933 A002995 A002961 A003008 A002769 A003033 A003038 A002971 A002972 A002934 A003007 A003010 A003039 A003047 A002973 A003031 A003014 A003055 A003036 A003081 A003042 A002807 A003046 A003050 A002974 A002860 A002879 A002983 A002944 A002958 A002986 A003002 A002881 A003086 A002918 A003059 A003089 A003107 A003113 A003001 A002952 A003069 A003070 A003092 A002938 A003041 A003083 A003103 A002916 A003071 A003009 A003131 A002929 A002913 A003097 A003120 A002988 A002991 A003099 A003076 A003101 A003049 A003145 A003114 A003110 A003106 A003084 A003079 A003096 A003082 A003027 A003142 A003126 A003006 A003140 A003112 A003137 A003152 A003087 A003026 A003052 A002990 A003098 A003025 A003054 A002182 A003134 A003072 A003045 A003161 A003173 A003188 A003018 A003060 A003167 A003146 A002948 A003012 A003056 A003109 A003061 A003028 A003144 A003159 A003176 A003206 A003136 A003141 A003121 A003169 A003183 A003166 A003230 A003232 A003204 A002898 A003080 A003195 A003196 A003085 A003205 A003198 A002185 A003094 A003192 A003233 A003216 A002822 A002828 A003164 A003165 A002815 A003062 A003133 A003149 A003151 A002827 A003119 A003148 A003199 A002785 A003063 A003180 A003178 A003215 A003058 A002857 A002796 A003156 A003237 A003225 A003162 A003193 A003229 A003258 A003243 A003272 A002198 A003262 A003265 A003278 A003207 A003266 A003234 A003240 A003210 A002835 A003128 A003184 A003174 A003242 A003264 A003256 A003200 A003267 A003231 A003251 A003160 A003255 A003150 A003223 A003170 A003185 A003306 A003281 A003068 A003190 A003275 A003299 A003091 A003279 A003303 A003273 A003253 A003326 A003247 A003268 A003296 A003323 A003305 A003314 A003244 A003254 A003308 A003283 A003352 A003249 A003292 A003201 A003269 A003295 A003301 A003298 A003311 A003288 A003214 A003163 A003153 A003248 A003257 A003364 A003263 A003307 A003359 A003286 A003095 A003290 A003277 A003338 A003328 A003309 A003331 A003366 A003333 A003157 A003381 A003116 A003355 A003368 A003361 A003401 A003371 A003398 A003321 A003334 A002992 A003313 A003293 A003336 A003345 A003383 A003408 A003422 A003078 A003346 A003340 A003349 A003354 A003377 A003385 A003410 A003339 A003213 A003177 A003276 A003394 A003291 A003143 A003384 A003418 A003416 A003425 A003327 A003372 A003397 A003456 A003375 A003347 A003376 A003430 A003437 A003438 A003428 A003462 A003294 A003388 A003448 A003363 A003348 A003228 A003406 A003435 A003475 A003391 A003487 A003389 A003402 A003486 A003528 A003319 A003341 A003420 A003423 A003461 A003474 A003468 A003469 A003530 A003115 A003424 A003460 A003557 A003350 A003473 A003477 A003483 A003488 A003514 A003489 A003433 A003502 A003351 A003478 A003495 A003527 A003535 A003519 A003029 A003034 A003503 A003507 A003570 A003467 A003525 A003566 A003562 A003022 A003032 A003537 A003582 A002209 A003117 A003403 A003564 A003479 A003444 A003577 A003500 A003544 A003567 A003591 A003565 A003579 A003605 A003584 A003602 A003658 A003532 A003436 A003399 A003493 A003587 A003599 A003597 A003548 A003612 A003585 A003571 A003450 A003586 A003395 A003312 A003594 A003558 A003593 A003611 A003620 A003644 A003569 A003439 A003441 A003636 A003405 A003504 A003590 A003429 A003168 A003622 A003603 A003432 A003614 A003606 A003672 A003638 A003512 A003598 A003668 A003688 A003518 A003520 A003572 A003645 A003641 A003580 A003626 A003660 A003656 A003523 A003683 A003679 A003684 A003619 A003714 A003738 A003674 A003669 A003442 A003508 A003731 A003722 A003993 A003494 A003601 A003608 A003685 A003665 A003616 A003747 A003677 A003463 A003510 A003538 A003627 A003659 A003671 A003470 A004009 A003724 A003733 A004004 A004006 A003817 A003807 A003682 A003821 A003632 A003809 A003814 A003845 A003687 A003730 A003737 A004001 A003409 A003415 A003734 A003813 A003650 A003661 A003623 A003678 A003739 A004015 A003613 A003715 A004012 A003825 A003830 A003250 A003592 A003651 A003686 A004003 A003252 A003713 A004023 A003756 A003648 A003992 A004020 A003844 A003771 A003522 A003604 A003832 A003751 A003783 A003646 A003706 A003445 A003824 A003803 A003446 A003700 A003775 A003990 A003847 A003846 A003837 A003705 A003697 A003850 A004008 A003757 A003862 A003869 A003721 A003859 A003801 A003855 A003662 A003768 A003770 A003767 A003874 A003881 A003885 A003772 A003843 A004027 A003691 A003863 A003891 A004026 A003799 A003708 A003878 A003880 A003798 A003417 A004007 A003773 A003723 A003858 A003774 A003505 A003727 A003750 A003805 A003866 A003865 A003758 A003640 A003888 A003994 A003820 A003864 A003911 A004018 A003754 A003903 A003759 A004024 A003915 A003979 A004078 A004037 A003976 A003981 A003838 A003860 A004085 A004112 A004189 A004102 A004158 A004108 A004062 A003703 A004109 A004042 A003940 A004227 A003741 A003792 A004066 A004052 A004173 A003883 A003897 A003941 A004081 A004115 A004048 A004232 A004075 A004228 A004114 A004059 A003812 A003895 A003898 A004311 A003559 A004180 A004187 A004339 A004234 A003853 A003963 A004258 A004010 A003904 A004126 A004273 A003795 A004293 A004123 A004301 A004276 A004304 A004087 A004367 A004104 A004328 A004281 A004353 A004392 A003625 A003907 A004309 A004375 A003800 A004333 A003854 A004456 A003790 A004538 A003909 A004460 A004637 A003912 A003946 A004153 A004156 A004257 A004317 A004378 A004390 A004396 A004402 A004412 A004422 A004426 A004428 A004485 A004655 A004685 A004445 A004446 A004457 A004475 A004513 A004525 A004529 A004553 A004558 A004560 A004566 A004572 A004579 A004589 A004597 A004649 A004665 A004669 A004702 A004713 A004732 A004734 A004147 A004550 A004657 A004681 A004718 A004722 A004686 A002846 A002853 A004719 A004723 A004729 A004735 A004469 A004470 A003861 A003932 A004693 A004696 A004603 A004602 A004255 A004323 A004094 A004095 A004489 A004627 A004662 A002834 A002840 A003543 A003575 A003624 A003735 A003736 A004000 A003698 A003765 A003804 A003876 A004013 A003892 A003893 A003894 A003910 A003987 A004058 A004082 A004110 A004047 A004130 A003929 A004144 A004174 A004202 A004216 A004203 A004200 A004238 A004251 A004263 A004275 A004280 A004287 A004305 A004237 A004297 A004320 A004325 A004336 A004338 A004324 A004300 A004319 A004322 A004341 A004210 A004298 A004351 A004206 A004321 A004347 A004312 A004314 A004335 A004337 A004330 A004332 A004364 A004370 A004358 A004385 A004363 A004377 A004386 A004365 A004383 A004393 A004379 A004380 A004398 A004415 A004441 A004413 A004430 A004340 A004421 A004424 A004429 A004433 A004448 A004443 A004414 A004434 A004408 A004417 A004440 A004399 A004400 A004425 A004427 A004449 A004458 A004442 A004437 A004315 A004536 A004486 A004541 A004542 A004466 A004483 A004468 A004471 A004516 A004271 A004490 A004463 A004478 A004480 A004500 A004474 A004498 A004505 A003890 A004492 A003902 A004510 A004495 A004496 A004497 A004502 A004535 A004527 A004537 A004585 A004606 A004607 A004617 A004635 A004638 A004563 A004646 A004629 A004639 A004540 A004626 A004659 A004660 A004654 A004648 A004667 A004650 A004599 A004691 A004334 A004578 A004672 A004676 A004680 A004683 A004699 A004716 A004666 A004710 A004041 A004057 A004121 A004124 A004182 A004459 A004493 A004519 A004524 A004555 A004565 A004580 A004593 A004598 A004636 A004671 A004674 A004724 A004726 A004733 A004737 A004741 A004743 A004745 A004747 A004260 A004590 A004601 A004612 A004651 A004658 A004664 A004670 A004701 A004715 A004721 A004742 A004749 A004750 A004751 A004754 A004756 A004757 A004763 A004765 A004770 A004772 A004773 A004774 A004780 A004781
Recalling Firm/
Manufacturer
Boston Scientific CRM Corp
4100 Hamline Ave N
Saint Paul, Minnesota 55112-5700
Manufacturer Reason
for Recall
An internal protective fuse can be unintentionally activated while the device is charging its capacitors for shock delivery or induction. Should this occur, the defibrillator would not be able to deliver therapy or communicate with the Q-TECH Model 2020 programmer, and would be unable to emit tones or otherwise respond to magnet application.
FDA Determined
Cause 2
DESIGN: Software Design
Action Consignees were sent a Boston Scientific "Important Medical Device Information" letter dated March 1, 2012. The letter was addressed to "Dear Doctor". The letter described the product involved in the recall, the problem and provided Recommendations/Actions. US customers may contact Technical Services for more information at 800-227-3422.
Quantity in Commerce 2090 (570 USA; 1520 OUS)
Distribution Worldwide Distribution, USA including the states of AZ, CA, CO, DC, GA, IL, MD, MA, MN, NJ, NY, NC, OH, PA, SC, VA, WA and the countries of AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, FRANCE, GERMANY, IRELAND, ITALY, NETHERLANDS, NEW ZEALAND, PORTUGAL, SLOVAKIA, SPAIN, SWEDEN, SWITZERLAND, and the UNITED KINGDOM.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = LWS and Applicant = CAMERON HEALTH
PMAs with Product Code = LWS and Applicant = CAMERON HEALTH, INC
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