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U.S. Department of Health and Human Services

Class 2 Device Recall Guide Catheter

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 Class 2 Recall
Guide Catheter
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Date Posted January 07, 2011
Recall Status1 Terminated on December 19, 2011
Recall Number Z-0885-2011
Recall Event ID 54685
Premarket Notification
510(K) Number
K980453 
Product Classification Catheter, Percutaneous - Product Code DQY
Product Boston Scientific Guider Softip TM XF Guide Catheter Catheter is intended to facilitate the placement of interventional devices into the neurovascular system.
Code Information 90525344AB-FA Glrider Urgent Medical Device Recall and Correction -Immediate Action Required 2462 LOTS/BATCH pirati<>n Date Ra.nge 01Nov2009 thru 260ct2012 " H965100420 H965100420 H965100420 H9651 00420 H955100420 H965100420 9150327 9311881 9512569 9722188 9722193 9722196 9741465 9758000 9758001 9758005 9758009 9758053 9788191 9788192 9790935 9790941 9790948 9804696 9822995 9523004 9823038 10000038 11014597 11015000 11015008 11015009 11015013 11028568 11028701 11031983 11031990 11046532 11047167 11047546 11047555 11066243 11066247 11066248 11066256 11064731 11084735 11064823 11101394 11101397 11102061 11102066 11102070 11102102 11116698 11117102 11117109 11334529 9157999 9311882 9547147 11117114 11334530 9158000 9311883 9547294 11117118 11334531 9168776 9311884 9547335 11117145 11334532 9167825 9311885 9547340 11153284 11334533 9167826 9311868 9547343 11153287 11352784 9167527 9326551 9547344 11153289 11369760 9167528 9326832 9551202 11157406 11369761 9174304 9326833 9585494 11157407 11381287 9175100 9346593 9565495 11157408 11381288 9178211 9346594 9565502 11164019 11381290 9178475 9346595 9565507 11178685 11381291 ¿9181933 9352723 9565510 11204169 11381292 9185775 9352730 9584450 11208272 11381293 9185776 9356559 9584514 11208365 11381294 9188899 9356560 9584523 11208367 11381295 9189029 9360472 9584826 11208368 11397844 9189030 9360473 9601921 11208369 11397845 9189372 9360474 9601925 11225810 11397846 9189373 9375348 9601932 11225812 11397847 9193197 9375349 9601936 11225970 11397848 9193611 9375350 9616758 11226005 11416545 9197095 9375657 9616767 11226007 11416546 9204045 9419745 9616768 11226008 11437038 9209187 9419746 9816794 11226009 11437039 9209188 9438379 9838424 11226010 11437120 9212568 9438380 9636429 11245824 11454913 9222969 9438381 9638433 11245825 11455368 9222970 9438382 9653896 11245826 11455854 9222971 9438383 9653900 11245827 11456257 9237028 9438384 9666293 11245828 11456258 9237029 9441911 9668294 11245837 11456280 9237037 9442073 9866297 11245838 11456281 9245645 9443461 9866302 11245839 11456282 9248676 9443462 9868309 11294639 11492380 9260179 9443464 9666311 11294640 11492381 9260613 9443465 9687123 11294641 11509643 9260623 9443467 9667129 11294642 . 11509644 9260624 9443468 9667130 11330740 11509645 9279838 9455245 9887335 11330741 11527879 9279839 9455360 9687341 11330742 11527920 9279841 9477253 9667344 11330743 11548119 9294029 9477254 9704042 11330744 11548120 9294166 9477255 9704044 11330745 11548121 9294168 9481504 9704075 11334341 11563467 9294170 9496560 9722176 11334527 11563468 9294172 9512562 9722180 11334528 11553472 . H965100420 c<>ntinues on next page Boston Scientific Corp Fonn Rcea1l Notifii:ation }'ackage Affectlld Product Full Listing 90205018 Re'JNer AA (10 pa,."""",b",""') Page 2 ofIO 90525344AB--FA Guider Urgent Medical Device Recall and Correction -Immediate Action Required H965100420 H965100420 H965100420 H965100420 H965100420 H9651OO430 12421304 12757498 9492009 11563475 11814605 12097012 12097013 12421305 12757499 9512563 11576832 11874324 12787721 12097014 12421306 9531415 11576837 11874325 12820101 12097015 12454419 9547336 11577226 11884827 12820102 12097016 12454520 9547349 11616910 11884863 12142381 12454521 12820104 9559440 11616911 11884865 12142365 12820106 9584516 11896649 12454522 11616912 12142387 12478181 12829045 9584529 11616913 11898650 12478183 12829048 9601930 11616914 11896651 12142388 11896652 12157388 12491443 12838530 9613169 11629213 12843099 12157389 12491444 9616797 11653719 11928855 12168732 12491445 blank 9628856 11653780 11928856 9636245 12188734 12510243 12850311 11653781 11928857 12510244 9636246 11653782 11928858 12168735 12869550 12179986 12869551 9638418 11671766 11928859 12510245 12195573 12890416 9636425 11671767 11928880 12510246 12195574 11671769 11928881 12525699 12890418 blank 11690595 12203112 12525710 12922863 9687124 11928882 11943386 12203113 12528600 blank 9704050 11690596 11690599 12528601 9722173 11943391 12240993 blank 11690760 11943395 12241486 12574411 9722178 blank 11690763 12583145 9722192 11943396 12241487 12940361 11960970 11690784 12241488 12583146 blank 9741455 11960971 12255982 11690767 12583147 12965144 9741456 11960972 11690768 12255985 12583148 13007450 9741457 11960973 11707451 12255986 12591684 13007451 9741461 11960974 12255987 12610499 13007452 9790937 11723304 12271421 11723305 11967690 12637958 ~~ 9807581 11723310 11967691 12271422 12638041 H965100430 9822993 11967692 12271423 12638042 9209191 11744938 9823012 12281478 11744939 11967694 12638043 9223018 11014591 12286949 11760881 11986697 12653358 9234516 11015005 12290310 11760882 11986698 12653359 9237027 11027565 11760883 12300749 12653400 12012853 9279650 11031424 11760884 12311588 12653401 12012892 9294158 11047624 11778342 12030004 12311589 12666665 9346551 11057266 11778343 12323164 12030007 12666666 9352580 11065003 12666667 11778344 12033603 12335406 9352731 11084732 12335412 12666668 11796536 12033604 9375351 11101390 12686064 11796537 12033605 12344455 11102060 9375852 11796821 12350241 12699171 11117144 12047380 9419737 11796822 12073877 12350243 12699172 9419738 11157409 12073878 12388986 12721866 11796823 9455240 11178861 12388967 11796827 12073879 12721867 9455373 11208271 11814801 12089264 12413103 12732809 9477469 11208361 11814802 12089267 12413104 12732810 9477477 11208363 12421303 11814803 12089269 12732811 9490008 11282792 H965100430 continues on .next page Boston Scientific Carp Form Recall Notification Package .Affected Product Fll1I Listing 9020507g~vNerAA (lOpage attacbmenl) Pagc30flO 90fi25344AB-FA Guider Urgent Medical Device Recall and Correction - Immediate Action Required H965100430 H965100430 H965100440 H965100440 H965100440 H965100460 11315668 12454414 9535314 11294635 12146647 94n468 11352781 12454415 9547345 11352751 9495419 12146648 11381340 9584449 11381297 12454416 12146648 9495427 9601914 11381298 12203119 9512559 11397854 12491450 9601923 11397849 12288703 11437026 12528555 9547341 12574406 9615737 11437036 11437028 12328161 9565500 11456249 12603873 9616757 11473722 12373274 9583242 12373275 11492273 12603674 9616793 11492268 9584517 12603675 11492270 11492274 9636414 12368961 9601934 11527924 12610493 9636426 11527877 12388962 9616366 11548113 12757494 11548115 12388963 9654706 9616686 11598110 12781236 9650403 11548117 12528154 9616761 11616902 12800329 11563469 9669596 12528556 9653901 11616903 11616737 12820108 9703670 12574410 9687132 11616904 9703672 11616739 12650307 12660333 9687343 11653784 9722183 11616901 9704045 12885990 12686083 9722197 ' 11629321 11690761 12896307 12714434 9790934 11629323 9811420 11760818 12918716 9734466 12757644 11690766 9822971 11n2120 12940364 9739064 12800330 ;t;~~~~.¿ .. ,~jjg7&;' l1n2123 9741483 11707448 12850308 9623036 9746285 11814809 11723300 blank 11015010 H965100440 11859096 9150328 9822972 11760891 blank 11031982 9161316 9823003 11771876 blank 11859097 11047625 11014596 11884832 9223216 11n1877 11068259 11884837 9237030 11015008 11771878 H965100460 11084820 11933139 9237031 11039012 11771879 9178479 11101398 11997671 9260825 11047545 11778155 9181941 11139226 11997672 9279847 11047559 11778156 9189374 11139239 11997673 9279651 11068244 11778157 9198020 11157405 12012880 11778158 9294156 11068251 9203786 11194291 11068307 11790247 12047384 9300879 9209186 11194292 12082501 11084730 11910560 9311887 9223213 11194297 12097018 11910562 9326638 11084825 9237032 11208276 12097019 9352578 11117111 11922107 9245646 11225972 12124401 9352579 11139230 11922108 11238494 9260615 12168781 11157414 11922109 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12421311 9584515 9237035 11015001 11245753 12424962 11943392 9616684 9272187 11282794 12473665 11960975 11043271 11068246 9616756 9294161 11330423 12491446 11986781 9636353 9294164 11331349 12528806 12012893 11102072 9636419 9296983 11352758 12574414 12047382 11117101 9311891 11369732 12610497 12097264 11178869 9666296 9687355 9326636 11369733 12113372 11245881 12696065 11416544 12686067 12142383 11397852 9704036 9326637 12142386 11437029 9722179 9346597 11466289 12732816 9741500 9356557 12195576 11492385 11473632 12732817 11031981 12203114 11527925 9360310 11473633 12772910 12267863 11047543 9419751 11527874 12813591 11577228 11068263 9437890 11548112 12281476 11616915 12972424 11690771 11102064 12311583 9450954 11563479 12972425 11117103 9450956 12311584 11707446 11598019 11263874 12335407 11859081 9468401 11598100 H965100510 12335413 11859083 11282788 9477482 11629217 9150330 12350139 11922112 11334662 9495422 11635617 9158002 12421312 11997669 11352780 9512553 11635618 9178474 11997670 11397856 12454533 9547149 11671438 9279544 12491352 11416548 9547355 120854B4 11671439 9294025 12491353 12157386 11436725 9584451 11723178 9311889 12240984 11437030 12491354 9601917 11723301 9326549 12583144 12244083 11437562 9616799 11745107 9395257 12610540 12373269 11577223 9636435 11778351 9395259 12373270 12686066 11690770 9666307 11814618 9455248 12686068 12483777 11707189 9680127 11814619 9473835 H965100510 continues on next page Boston Scientific Corp Fonn Recall Notification Package Affected Product FuJI Listing 90205078 RevNer AA (10 page at'l:at;~nr) PageS oflO 90525344AR-FA Guider Urgent Medical Device Recanand Correction -Immediate Action Required' H965100510 I H965100510 I H965100520 MOO3100620 M0031 00620 M003100620 9237025 11334561 9666312 9495559 j 12904246 t11263864 9524733 11263866 9237039 11352766 9680617 11352757 H965100520 11263960 9260616 9584446 9687349 9189375 11352742 9260617 9701885 11416419 9601938 9226691 11372960 9279842 9701886 11437126 9616690 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12757493 11245836 9223212 9653589 11294637 12281477 1282a109 11250354 9237024 9653590 11334580 12311590 M0031 00620 continues on next page BostQn Scientific Corp POJm Recall Notification Package Affected Product Full Listio;g 90205078RevNer AA (10 page attachment) Page 6 of10 90525344AB-FA Guider Urgent Medical Device Recall and Correction - Immediate Action Required MOO3100620 M003100630 M003100640 MOO3100640 M003101420 MOO3101420 9648461 11653785 9189376 9565491 9219848 12323059 11690765 9189377 9565493 9294026 12323160 9651751 11707193 9565496 9311476 9209185 9680542 12355834 11707194 9565506 9326547 9209395 12373277 9704038 11707195 9741471 9356238 9209396 9564447 12388970 11707197 9209397 9584448 9811418 12454527 9356240 11723302 9209398 9584527 9822985 9356558 12491355 11723306 9237033 9801915 11011722 9400641 12491357 9401230 12012887 9237038 9801919 11011895 12491358 12157318 9260620 9616759 11031690 9450953 12582938 12179498 9260621 9636417 12603676 11064928 9465239 9457568 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9822999 blank blank 11760897 11047549 12800334 9455243 9823007 11772127 13029815 11068249 12817335 9455375 11014792 11800167 11084824 12817336 11014988 ~!&~',,%[,i,~~d~~ 9465376 11102063 M003100630 11980978 12817337 9470050 11015012 11139228 9237036 12300746 12817339 11031986 9477479 9260618 11145815 12323163 12817401 9477481 11038897 11161098 12619774 9279846 12336406 9491609 11042013 9279647 12454532 11178864 12819776 9497655 11047626 12574408 11194340 9294030 12860860 11068254 9502073 12707324 11262782 12896304 9369944 9502074 11068304 12776965 11282783 13029616 9497165 9505697 11084727 12843098 . 11294630 9526016 ¿¿~~~~1!~2Z~~f, 9512554 11084622 9565506 12869546 11372919 M003101420 11099803 9512555 12929572 11473634 9150326 11101471 9560406 9531266 blank 11577225 9158776 11102067 9616796 9547151 9636423 11598017 9176210 9547152 11139234 M003101420 continues on next page Boston Sc1entific Corp Form Recoil NotificationPackage A:ffi:cted ProductFl.lll Listing 90205078 RJ:.vNer AA (10""",_) Page 7 0¿10 90525344AB-FA Guider Urgent Medical Device Recall and Correction -Immediate Action Required M003101420 M003101420 MOO3101420 M003101420 M003101430 MOO3101430 12610541 11960977 9722052 12546575 11139238 11509636 11974878 12670517 9722191 12610494 11156212 11509637 11974879 12670509 12670519 9741502 11157020 11546123 12670560 12699167 11157179 12004404 9790688 11546125 12012869 12707328 11157400 11563477 9822994 12699168 12714437 11157401 11576831 12012890 11031699 12699169 12030003 12721863 11178883 11598012 11047556 12843097 11598013 12030006 12757640 12850302 11194343 11084821 11598014 12046076 , 12757641 11139054 11194344 12869549 11598015 11194345 12046077 12800335 11139055 biank 12074000 11598016 12800337 11142237 f:f~~;;t~{~~;~'*~:t~~ 11204526 12074001 11616918 12838526 11157404 11208274 M003101440 12089265 11208382 11629209 12869547 11178870 9360475 12097265 11206364 11635787 12890415 11225977 9409892 11635788 12121032 11225978 12890417 11282784 9419776 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11372917 12421309 9519808 11814616 11997676 9785036 11372918 11814617 12454417 9523543 11997677 9822962 11416415 11896682 12454418 9523644 12046079 11014592 11416416 12478182 9523545 12074007 11896684 11024516 11416417 12491447 9565509 12121030 11928863 11061796 11473636 12510241 9581371 11928884 12157384 11068242 11473637 12528152 9616685 11928885 12274976 11101399 11473638 12528153 11928886 9616766 12300745 11139229 11473639 11943388 12528559 9636416 12323056 11146795 11492277 12546644 11943393 9653899 12421310 11157174 11492278 11943397 12570412 9686303 12483778 11178673 11509634 11943399 12571456 9689612 12520761 11208277 12574412 11509635 11960976 9704073 12539141 11215022 M003101440 continues on next page Boston Sdootific Corp Fonn RecaI1 Notificalion Package Affected Prudnct Full Listing 90205078 RevNer AA (10 page _1mlent) PageBoflO 90525344AB-FA Guider Urgent Medical Device Recall and Correction - Immediate Action Required M003101440 Il1003101460 Il1003101480 M003101480 I M003101440 I M003101460 12574413 12732818 11178577 9450959 11232472 ~11178578 12610496 9476296 12850305 11232474 12721870 blank 11263966 M003101460 11263935 9495416 r~'M:;~t-%;;~~;y{j;~;; 11263936 blank 11263967 9161317 9495417 9161318 11263937 12781344 9495421 MOO3101500 11282791 11381341 12838528 9496429 9150329 9178478 11282474 12922868 11397853 9223214 11282787 9512567 9158001 11416541 9234517 11283019 12922869 9531270 9161319 11294632 9653591 11527868 9237026 9204044 ,11294643 MOO3101470 11563503 9237040 9687333 9208446 11294644 11576836 9240961 9245640 9721984 9245641 11397858 11616906 9279834 9294028 9741469 9294155 11616908 9279835 11397859 9473712 11014595 9311890 9294027 11397880 9601920 11049013 11635780 9346596 11707449 9312017 11509646 9616763 11068250 9353826 11723175 11598009 11031693 11077203 9359943 9346540 11723177 9348588 11598010 11047622 11101392 9398514 11598011 11117142 11157172 11796826 9375346 9398515 11157413 11814807 9400838 11635790 11157173 9398520 11854996 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Bosaon Sc.:ienJific CorpFormRecaJ] NotificatianPlU:bge A:ffucled Product Full Lisliag 90205078 RtlINr:r AA (10 page auaebmeot) Page 1 ofJO
Recalling Firm/
Manufacturer
Boston Scientific Corporation
47900 Bayside Pkwy
Fremont, California 94538-6515
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
Complaint about product quality: degradation of polymer portion of the distal section of the catheter.
FDA Determined
Cause 2
MISBRANDING: Labeling False and Misleading
Action Boston Scientific sent an Urgent Medical Device Recall and Correction letter dated December 18, 2009, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for the affected product and fill out the Customer Instructions and REPLY VERIFICATION TRACKING FORM indicating the status of the affected product and send a copy of the form by fax to 510-624-1600 or e-mail to Joe.Nesci@beci.com.
Quantity in Commerce 94,296 units
Distribution Worldwide. US Domestic including US Federal Government, and foreign countries.
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.
510(K) Database 510(K)s with Product Code = DQY and Original Applicant = BOSTON SCIENTIFIC SCIMED, INC.
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