Events

Boston Scientific Matrix2 360 UltraSoft SR Coils 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    57179
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0863-2011
  • 사례 시작날짜
    2010-10-19
  • 사례 출판 날짜
    2011-01-05
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-01-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96169
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    vascular embolization device - Product Code HGC
  • 원인
    The product appears to have premature degradation of the pgla coating on the matrix coil.
  • 조치
    US consignees were notified by letter sent by Federal Express on October 19, 2010. Customers out of the United States were notified by Federal Express if possible and by personal delivery by locally assigned sales representatives as needed.

Device

Boston Scientific Matrix2 360 UltraSoft SR Coils
  • 모델명 / 제조번호(시리얼번호)
    Material Product Description Catalog # Batch numbers Expiry Date   11252230,11308509,11314276,11325957,   11336598, 11393159, 11395513, 11407112,   11451244,11531641,11550997,11560540,   11591562,11591706,11622023,11658783,   11658785,11658822,11676148,11676157,   11719463, 11730234, 11790200, 11800701,   11800705,11820288,11850793,11850843,   11873434,11908088,11934094,11958442,   11958449,11958467,11975078,11975174,   12018396,12061956,12082830,12093269,   12102499, 12102571, 12112302, 12119035,  M003498204SRO Matrix2¿ 360 UltraSoft SR Coils 498204-SR 12130177,12156608,12156619,12172635, Oct2010 through   2mm x4cm 12175697,12176083,12176088,12176096, Aug2013   12176113,12176130,12214865,12229603,   12229665,12229709,12300883,12304385,   12316893,12330638,12372623,12383765,   12388036,12498742,12514610,12549119,   12549517,12579004,12669973,12670052,   12702899,12703158,12721628,12748406,   12775526,12792905,12810367,12847198,   12856251,12861682,12861685,12861728,   12902495,12909257,12920788,12922010,   12922031,12947555,13165095,13182078,   13740728   11285904, 11325811, 11330308, 11336721,   11344686,11429308,11430218,11491190,   11535756,11551320,11580678,11586999,   11606468,11640887,11676151,11676165,   Matrix2¿ 360 UltraSoft SR Coils 11792442,11820281,11820295,11850792, Oct2010 through  M003498206SRO 498206-SR 11850844,12043227,12119036,12130803,   2mm x6cm 12130817,12194743,12229581,12229605, Jun2013   12299406,12304391,12514596,12549520,   12650936,12792884,12861539,12861681,   12861726,12929268,12947551,12982270,   13165082,13165102,13600453   11290821,11306854,11414844,11415101,   11488903,11524527,11535144,11598085,   11658796,11730211,11756822,11800379,   11850788,11873437,11889319,11889933,   11958235,11958447,11975073,11975199,   11992222,12009642,12043109,12082849,   12102496,12112306,12130249,12156604,   Matrix2¿ 360 UltraSoft SR Coils 12156607,12156621,12172961,12175696, Oct2010 through  M003498304SRO 498304-SR 12175827,12176080,12176086,12176101,   3mm x4cm 12229674,12229678,12304388,12315366, Jan2013   12330621,12368749,12370624,12374136,   12374221,12376353,12379817,12383766,   12514603,12541587,12549512,12549525,   12579028,12636755,12703154,12703190,   12748467,12792896,12861696,12902497,   12922003,12922028,12947530,13165085,   13165101,13198188,13204883,13230537    I 11302950,11385614,11385615,11403344,   11440497,11444540,11475012,11523684,   11552540,11591597,11598082,11622020,   11640889, 11676150, 11730057, 11730213,   11788744, 11820175, 11820292, 11836537,   11850840,11873438,11908089,11925597,   11958473,11975164,11975183,11992201,   12009563,12009573,12009640,12026744,   12043228, 12067385, 12082843, 12082859,   Matrix2¿ 360 UltraSoft SR Coils 12112303,12127498,12142026,12142038, Oct2010 through  M003498306SRO 498306-SR 12176131,12188229,12194499,12194715,   3mm x6cm 12194731,12214717,12214815,12214857, Aug2013   12229662, 12299405, 12304191, 12304196,   12368752,12388034,12396262,12418213,   12424869,12427988,12439191,12439351,   12549523,12636732,12636756,12670041,   12702896,12703155,12703187,12753182,   12783356,12792890,12792921,12858819,   12861684, 12861720, 12922011, 12929262,   13109928, 13165083, 13165093, 13606646,   13740721   11321963,11325815,11341602,11440812,   11444365, 11488901, 11489569, 11550743,   11560542, 11598086, 11658799, 11730230,   11788749,11820283,11850855,11916970,  M003498308SRO Matrix2¿ 360 UltraSoft SR Coils 498308-SR 11958232, 11958238, 11958448, 11958466, Nov2010 through   3mm x8cm 11996497,12102567,12130806,12194700, Jun2013   12194723,12214852,12229590,12549509,   12578759,12636733,12810343, 12885370,   12918062,12942555,12946179,13118674,   13165108,13182069,13600456   11293279,11318108,11345092,11407741,   11489572,11538865,11580677,11586997,   11658786,11712101,11719464,11789879,   11792443, 11820170, 11820282, 11850856,   11889925,11958236,11958456,12021661,   Matrix2¿ 360 UltraSoft SR Coils 12026495,12026742,12082848,12112305, Oct2010 through  M003498406SRO 498406-SR 12141859,12142033,12186120,12194702,   4mm x6cm 12194724, 12214850, 12229704, 12295452, Jun2013   12296704,12315362,12330599, 12439225,   12514516,12549514,12570929, 12669968,   12670046,12779824,12792888, 12805886,   12899134,12922013,12947538,13112464,   13165107,13610468 .   11314326,11320203,11336864,11396043,   11444147,11444545,11489567,11523682,   11538870, 11552547, 11560546, 11591708,   11658820,11676163,11676203,11788743,   11820174, 11820287, 11850846, 11873436,   11925602,11938492,11975160,11975176,   11975222,11992210,12009652,12061958,   12074313,12082844,12102564,12110478,   Matrix2¿ 360 UltraSoft SR Coils 12119835, 12130819, 12194486, 12194491, Oct2010 through  M003498408SRO 498408-SR 12194701,12194717,12194737,12214191,   4mm x8cm 12214718,12214817,12299414,12300716, Jun2013   12304387, 12330612, 12330647, 12385409,   12409147,12413139,12424873,12424877,   12439196, 12439352, 12567224, 12579029,   12669005, 12703185, 12721626, 12748407,   12783357,12791150,12922015,12929076,   12929261,12947543,12982329,12982336,   13116525,13164430,13165087,13182068,   13182074, 13602977   11321964, 11322842, 11432824, 11485038,   11531649, 11591564, 11591700, 11676177,   11697470,11712102,11719465,11721430,   11820323,11889309,11889316,11916971,   11952857,12026496,12043224,12061790,   12115320,12119907,12130813,12142087,  M003498510SRO Matrix2¿ 360 UltraSoft SR Coils 498510-SR 12194718,12214197,12214714,12214842, Nov2010 through   5mmx10cm 12267364, 12304383, 12311944, 12315361, Jun2013   12315363,12356259,12392931,12404359,   12418210, 12439358, 12549513, 12634217,   12703183,12748428,12791153,12792898,   12861694,12922006, 12929075, 13164428,   13164795,13165092,13195731,13200123,   13233310,13603121   11323634,11325812,11329547,11403547,   11552535,11591701,11711974,11711979,   Matrix2¿ 360 UltraSoft SR Coils 11766679, 11838297, 11850794, 11908093, Nov2010 through  M003498515SRO 498515-SR 11946180,11991286,12214846,12226292,   5mmx15cm 12229666,12306631,12446872,12468830, Oct2012   12495253,12514592,12523445, 12579019,   12810368,12914092,12946427,13113054   11281623, 11380106, 11552542, 11658791,   Matrix2¿ 360 UltraSoft SR Coils 11748395,11889312,12061947,12115321, Oct2010 through  M003498610SRO 498610-SR 12142031,12299316,12370621,12446874,   6mmx10cm 12514609,12632702,13118675,13165080, Aug2013   13740727   11322855, 11385261, 11486201, 11531652,   Matrix2¿ 360 UltraSoft SR Coils 11591702,11658823,11697473,11800199, Nov2010 through  M003498615SRO 498615-SR 12194497, 12214193, 12226290, 12229705,   6mmx15cm 12439187,12491070,12495248,12514597, Aug2013   12947527,12965255,13740729
  • 의료기기 분류등급
    Obstetrical and Gynecological Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution. USA, Argentina, Austria, Australia, Belgium, Bahrain, Brazil, Canada, Switzerland, Chile, China, Colombia, Serbia, Czech Republic, Germany, Denmark, Spain, Finland, France, Great Britain, Greece, Hong Kong, Hungary, Ireland, India, Israel, Italy, Jordan, Japan, South Korea, Lithuania, Latvia, Macau, Mexico, Malaysia, Netherlands, Norway, New Zealand, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovakia, Thailand, Taiwan, Turkey, Ukraine, Vietnam, and Yemen.
  • 제품 설명
    Boston Scientific brand Matrix2 360 UltraSoft SR Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature.
  • Manufacturer
    Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538

Manufacturer

Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538
  • 제조사 주소
    Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538, 47900 Bayside Pkwy, Fremont CA 94538-6515
  • 제조사 모회사 (2017)
    Boston Scientific
  • 제조사 의견
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    USFDA