Devices

Device Recall Atlantis(r) SR Pro 2, 40 MHz Coronary Imaging Catheter

  • 모델명 / 제조번호(시리얼번호)
    All lots are impacted. 13478001, 13479862, 13483687, 13483794, 13486679, 13488281, 13492691, 13495381, 13495537, 13501702, 13509959, 13510363, 13510388, 13510970, 13513269, 13513370, 13518405, 13522499, 13525880, 13526246, 13529890, 13532559, 13532599, 13534080, 13537206, 13537450, 13541221, 13542989, 13543371, 13543372, 13543373, 13543374, 13543903, 13544086, 13548035, 13550071, 13551639, 13555107, 13557249, 13558528, 13560226, 13561192, 13561925, 13565449, 13572049, 13575534, 13576371, 13582549, 13587068, 13589401, 13591521, 13595076, 13598770, 13602027, 13604910, 13605911, 13607907, 13612369, 13613621, 13616694, 13617441, 13620814, 13623271, 13625428, 13627096, 13627610, 13628377, 13628378, 13628480, 13642454, 13644574, 13645440, 13648480, 13649064, 13649555, 13651806, 13659069, 13660352, 13663881, 13666991, 13670858, 13671958, 13675335, 13677173, 13679538, 13681808, 13685028, 13692281, 13711461, 13717161, 13721872, 13726417, 13729970, 13733692, 13736433, 13738543, 13744275, 13748118, 13751320, 13753544, 13755722, 13763259, 13766230, 13770525, 13772349, 13774311, 13779785, 13790510, 13795482, 13796520, 13799042, 13803863, 13807009, 13807405, 13810319, 13811040, 13813370, 13817138, 13823987, 13827155, 13828363, 13830503, 13834945, 13837411, 13846140, 13862022, 13866829, 13867763, 13867812, 13869465, 13871530, 13874961, 13874989, 13878848, 13881217, 13881902, 13883719, 13886293, 13889336, 13889690, 13892663, 13893369, 13897082, 13900781, 13906150, 13908756, 13909098, 13909550, 13909967, 13912695, 13913663, 13915857, 13916951, 13916953, 13920105, 13920710, 13920803, 13920805, 13921106, 13923537, 13924672, 13927066, 13928293, 13930289, 13932251, 13932695, 13935416, 13935514, 13936063, 13938497, 13938680, 13940859, 13943943, 13947364, 13950149, 13960559, 13964584, 13967316, 13970980, 13977845, 13982090, 13987794, 13990244, 13994171, 13997365, 14001705, 14006979, 14023919, 14032268, 14036676, 14038052, 14043294, 14048150, 14052253, 14054270, 14057246, 14059185, 14060218, 14060730, 14063990, 14064764, 14068345, 14071841, 14075967, 14075968, 14080311, 14081712, 14083655, 14086847, 14090453, 14090833, 14094058, 14098066, 14099289, 14101324, 14102725, 14105453, 14106322, 14109716, 14109807, 14113183, 14117941, 14125549, 14137883, 14140518, 14144461, 14147692, 14154145, 14156848, 14162309, 14164380, 14165091, 14167666, 14179509, 14183540, 14186298, 14191171, 14194753, 14198644, 14202609, 14203395, 14206342, 14206443, 14209358, 14210282, 14217182, 14219362, 14219394, 14226258, 14230360, 14235075, 14238057, 14239219, 14253978, 14255111, 14256086, 14256852, 14257870, 14258124, 14258292, 14260466, 14262256, 14267351, 14272686, 14272726, 14274123, 14275822, 14276666, 14278698, 14279887, 14280587, 14283635, 14285242, 14287832, 14289523.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and Puerto Rico and the countries of Japan, Trinidad, Tobago, and American Virgin Islands.
  • 제품 설명
    Boston Scientific iCross, 40 MHz Coronary Imaging Catheter, 3.6F (1.18mm) x 135 cm, REF / Catalog No. 51805, UPN / Product No. H749518050, Sterilized using irradiation, Made in USA 47900 Bayside Parkway, Fremont, CA 94538 || This catheter is intended for ultrasound examination of coronary intravascular pathology only. Intravascular Ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.
  • Manufacturer
    Boston Scientific Corporation
  • 1 Event

제조사

Boston Scientific Corporation
  • 제조사 주소
    Boston Scientific Corporation, 1 Scimed Pl, Maple Grove MN 55311-1565
  • 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