| Class 2 Device Recall Guide Catheter | |
Date Initiated by Firm | December 18, 2009 |
Date Posted | January 07, 2011 |
Recall Status1 |
Terminated 3 on December 19, 2011 |
Recall Number | Z-0885-2011 |
Recall Event ID |
54685 |
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
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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 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M003100640 MOO3101460 M003101510 M003101640 Find lot number listed under respective UPN in the following pages. 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 CA 94538-6515
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For Additional Information Contact | 510-624-2544 |
Manufacturer Reason for Recall | Complaint about product quality: degradation of polymer portion of the distal section of the catheter. |
FDA Determined Cause 2 | Other |
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 |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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