Devices

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

  • Model / Serial
    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.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Puerto Rico and the countries of Japan, Trinidad, Tobago, and American Virgin Islands.
  • Product Description
    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

Manufacturer

Boston Scientific Corporation
  • Manufacturer Address
    Boston Scientific Corporation, 1 Scimed Pl, Maple Grove MN 55311-1565
  • Manufacturer Parent Company (2017)
    Boston Scientific
  • Manufacturer comment
    “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