Device Recall Stonetome

  • Model / Serial
    All lots. Lots 588218, 7173503, 7907512, 8541152, 6553517, 7209058, 7923845, 8541153, 6573307, 7213538, 7938899, 6593724, 7238048, 7959199, 6628839, 7244918, 7978741, 6650500, 7312261, 7988003, 6663230, 7323058, 8012669, 6684869, 7345074, 8037031, 6684870, 7368731, 8056507, 6710850, 7394062, 8076206, 6731508, 7416357, 8076207, 6745329, 7441769, 8093643, 6762317, 7469187, 8115498, 6783937, 7487245, 8131913, 6798010, 7510076, 8146780, 6811675, 7536508, 8154851, 6832811, 7550048, 8165619, 6834085, 7570081, 8194623, 6843046, 7592340, 8221047, 6870688, 7613897, 8250992, 6893879, 7635034, 8262323, 6896571, 7635532, 8272381, 6917737, 7656406, 8301236, 6919072, 7701169, 8303922, 6939764, 7722952, 8304044, 6946002, 7738501, 8304054, 6965093, 7738922, 8326168, 6979350, 7773671, 8331426, 6988355, 7794744, 8337750, 7005425, 7813723, 8359941, 7037237, 7833511, 8378721, 7049995, 7833512, 8393169, 7052629, 7845564, 8414769, 7076211, 7845565, 8428051, 7096493, 7864321, 8444985, 7121618, 7891878, 8461221, 7143069, 7892977, 8489777, 7163174, 7900869 and 8509967.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Arab Emirate, Australia, Austria, Belgium, Canada, Denmark, Finland, France, germany, Great Britain, Hong Kong, Israel, Italy, Japan, Libya, Mexico, Netherlands, New Zealand, Portugal, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Turkey, Taiwan, Venezuela and Viet Nam.
  • Product Description
    Boston Scientific Stonetome Stone Removal Device, 20 mm tip, 20 mm cut wire, distal balloon, sterile, single use only, material number M00535110; catalog number 3511.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Boston Scientific Corp, 780 Brookside Dr, Spencer IN 47460-1080
  • Source
    USFDA

5 devices with a similar name

Learn more about the data here

  • Model / Serial
    All lots. Lots 558552, 7739212, 602212, 7753189, 6593723, 7794743, 6632145, 7814338, 6666397, 7836676, 6685227, 7864847, 6713444, 7885211, 6732190, 7938898, 6746552, 7959197, 6787368, 7979136, 6795091, 7997847, 6834079, 8001283, 6846985, 8079834, 6874028, 8119586, 6897533, 8133511, 6900226, 8170294, 6948065, 8203324, 6966289, 8250997, 6987748, 8306742, 6988354, 8306923, 7037239, 8409135, 7052984, 8430041, 7078441, 8459615, 7189065, 8533268, 7213471, 7244925, 7323059, 7351026, 7403584, 7442556, 7485763, 7536756, 7557104, 7656402, 7675613, 7701170 and 7722953.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Arab Emirate, Australia, Austria, Belgium, Canada, Denmark, Finland, France, germany, Great Britain, Hong Kong, Israel, Italy, Japan, Libya, Mexico, Netherlands, New Zealand, Portugal, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Turkey, Taiwan, Venezuela and Viet Nam.
  • Product Description
    Boston Scientific Stonetome Stone Removal Device, 20 mm tip, 30 mm cut wire, distal balloon, sterile, single use only, material number M00535130; catalog number 3513.
  • Manufacturer
  • Model / Serial
    All lots. Lots 603391, 6799504, 7037095, 7403583, 7747718, 8005961, 8358477, 6539142, 6800398, 7049985, 7416358, 7760416, 8017560, 8358478, 6546666, 6817098, 7049986, 7417916, 7761394, 8018138, 8379614, 6553801, 6817103, 7053803, 7435843, 7761853, 8032106, 8388053, 6553902, 6828542, 7066018, 7441770, 7786226, 8032115, 8400748, 6565305, 6828544, 7079432, 7462728, 7786735, 8051884, 8400749, 6573305, 6846542, 7097700, 7462729, 7802332, 8056988, 8422201, 6573599, 6846543, 7097887, 7468203, 7807099, 8071999, 8422445, 6591126, 6854647, 7119562, 7485762, 7814339, 8072078, 8423915, 6600353, 6856256, 7119563, 7490850, 7819437, 8093644, 8428272, 6603310, 6866068, 7135244, 7510077, 7834051, 8098020, 8450926, 6612042, 6866800, 7137004, 7510139, 7836780, 8098242, 8452464, 6622542, 6866801, 7143070, 7529920, 7844585, 8109397, 8465129, 6624628, 6880631, 7162295, 7529921, 7850336, 8109398, 8465132, 6639865, 6880632, 7171662, 7549824, 7852743, 8119584, 8481185, 6639866, 6882924, 7172639, 7561807, 7870482, 8129662, 8481186, 6642282, 6882925, 7194509, 7570701, 7870483, 8129666, 8502291, 6654412. 6882926, 7196785, 7580070, 7874768, 8142554, 8502292, 6654414, 6905787, 7215344, 7596810, 7874769, 8146781, 8529548, 6655006, 6905789, 7226282, 7601687, 7888575, 8151220, 8529873, 6688430, 6928345, 7230675, 7614631, 7889310, 8151399, 8534044, 6688431, 6930039, 7230717, 7622178, 7893150, 8162009, 8551812, 6705783, 6930823, 7240370, 7636172, 7900338, 8165618, 6706029, 6930828, 7255850, 7644297, 7903556, 8185320, 6706030, 6944021, 7255852, 7644959, 7907510, 8206062, 6722148, 6944023, 7281821, 7660740, 7919430, 8206395, 6722149, 6945019, 7283356, 7669404, 7919806, 8229567, 6723458, 6965086, 7298816, 7685490, 7924565, 8229568, 6742385, 6965087, 7309412, 7685991, 7940070, 8241697, 6742386, 6965092, 7321591, 7696885, 7947076, 8241698, 6742387, 6987554, 7321593, 7697518, 7947978, 8262517, 6761469, 6987555, 7343776, 7709157, 7969329, 8272091, 6761470, 7005426, 7344057, 7717440, 7971757, 8307578, 6771563, 7008933, 7367660, 7733590, 7978424, 8319259, 6771840, 7009025, 7367661, 7742542, 7978758, 8331425, 6780209, 7026602, 7392895, 7745771, 7997846, 8341585, 6799502, 7035326, 7392896, 7747717, 8002443 and 8341586.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Arab Emirate, Australia, Austria, Belgium, Canada, Denmark, Finland, France, germany, Great Britain, Hong Kong, Israel, Italy, Japan, Libya, Mexico, Netherlands, New Zealand, Portugal, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Turkey, Taiwan, Venezuela and Viet Nam.
  • Product Description
    Boston Scientific Stonetome Stone Removal Device, 5 mm tip, 20 mm cut wire, proximal balloon, sterile, single use only, material number M00535150; catalog number 3515.
  • Manufacturer
  • Model / Serial
    All lots. Lots 6546667, 6602514, 6706832, 6763251, 6811777, 6848204, 6930829, 7022531, 7078442, 7172641, 7283354, 7375263, 7467937, 7620507, 7725395, 7752678, 8037806, 8133510, 8230614, 8331439, 8360757, 8360758, 8384930, 8384931, 8411892, 8411893, 8411894, 8411895 and 8534126.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Arab Emirate, Australia, Austria, Belgium, Canada, Denmark, Finland, France, germany, Great Britain, Hong Kong, Israel, Italy, Japan, Libya, Mexico, Netherlands, New Zealand, Portugal, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Turkey, Taiwan, Venezuela and Viet Nam.
  • Product Description
    Boston Scientific Stonetome Stone Removal Device, 20 mm tip, 20 mm cut wire, proximal balloon, sterile, single use only, material number M00535170; catalog number 3517.
  • Manufacturer
  • Model / Serial
    All lots. Lots 224690, 7576902, 6546668, 7701654, 6573600, 7718121, 6603846, 7773069, 6662859, 7803065, 6689054, 7823006, 6706833, 7852755, 6734078, 7865546, 6747479, 7884781, 6763254, 7900823, 6800397, 7918903, 6828545, 7938897, 6874720, 7959841, 6901256, 8012981, 6905390, 8037505, 6930831, 8052326, 6950302, 8114299, 6987742, 8185319, 7037096, 8221046, 7067306, 8251275, 7078440, 8301234, 7121617, 8319260, 7143071, 8360762, 7172640, 8384933, 7215343, 8411896, 7254598, 8415192, 7283355, 8453123, 7309110, 8481169, 7353543, 8533265, 7375265, 7394060, 7418357, 7442997, 7490851, 7544533, 7576853, 7593007 and 7660576.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Arab Emirate, Australia, Austria, Belgium, Canada, Denmark, Finland, France, germany, Great Britain, Hong Kong, Israel, Italy, Japan, Libya, Mexico, Netherlands, New Zealand, Portugal, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Turkey, Taiwan, Venezuela and Viet Nam.
  • Product Description
    Boston Scientific Stonetome Stone Removal Device, 5 mm tip, 30 mm cut wire, proximal balloon, sterile, single use only, material number M00535190; catalog number 3519.
  • Manufacturer
  • Model / Serial
    All lots. Lots 6604751, 6689295, 6802779, 6848203, 6905391, 7053955, 7098448, 7189064, 7353544, 7442998, 7592642, 7676907, 7703438, 7802899, 7852756, 7938900, 8002453, 8271737 and 8502059.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Arab Emirate, Australia, Austria, Belgium, Canada, Denmark, Finland, France, germany, Great Britain, Hong Kong, Israel, Italy, Japan, Libya, Mexico, Netherlands, New Zealand, Portugal, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Turkey, Taiwan, Venezuela and Viet Nam.
  • Product Description
    Boston Scientific Stonetome Stone Removal Device, 20 mm tip, 30 mm cut wire, proximal balloon, sterile, single use only, material number M00535210; catalog number 3521.
  • Manufacturer