Devices

Device Recall MICROVASIVE GOLD PROBE

  • Modèle / numéro de série
    Lot Numbers for UPN M00560220: 9291645, 9344981, 9394026, 9416584, 9462927, 9501324, 9559362, 9581713, 9636705, 9670186, 9690901, 9741754, 9754809, 9754810, 9754811, 9815965, 9819629, 11006445, 110039853, 11042217, 11129600, 11168985, 11175063, 11234903, 11268506, 11282762, 11327776, 11361680, 11405398, 11445120, 11499437, 11522023, 11540259, 11577720, 11598340, 11647351, 11680236, 11713017, 11751140, 11786708, 11827587, 11850720, 11913776, 11943552, 11961965, 11997177 and 12077478.
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution.
  • Description du dispositif
    Gold Probe 7FR Working Length: 350 cm, Probe Tip O.D. 2.3 mm (7Fr), Rx Only. Electrical Connector: Standard. Single Use Only. Legal Manufacturer, Boston Scientific Corporation, One Boston Scientific Place Natick, MA 01760-1537 USA. Made in USA: 8600 N.W. 41st Street Miami, FL 33166-6202 USA. || The device is indicated for use in transendoscopic electrocautery of visible bleeding and nonbleeding sites in the gastrointestinal tract including the esophagus, stomach, duodenum, and colon.
  • Manufacturer
    Boston Scientific Corporation
  • 1 Event

Fabricant

Boston Scientific Corporation
  • Adresse du fabricant
    Boston Scientific Corporation, 8600 Nw 41st St, Miami FL 33166-6202
  • Société-mère du fabricant (2017)
    Boston Scientific
  • Commentaire du fabricant
    “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

2 dispositifs médicaux avec un nom similaire

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Device Recall MICROVASIVE GOLD PROBE
  • Modèle / numéro de série
    Lot Numbers for UPN M00560070: 9237058, 9242307, 9246342, 9265070, 9268728, 9272427, 9298292, 9302175, 9320321, 9324018, 9335827, 9341572, 9359902, 9376203, 9386673, 9390027, 9406078, 9410110, 9420346, 9425527, 9437988, 9443899, 9447626, 9466351, 9470374, 9482071, 9486110, 9489319, 9513036, 9517669, 9525255, 9528819, 9539767, 9544065, 9547291, 9574443, 9578122, 9602462, 9602528, 9606498, 9620098, 9623071, 9623100, 9623197, 9623397, 9632534, 9663181, 9666486, 9684482, 9684484, 9684485, 9689670, 9703937, 9708837, 9734006, 9746669, 9749624, 9749625, 9749627, 9750734, 9760158, 9770675, 9772909, 9783444, 9791088, 9827743, 9830764, 11002747, 11014998, 11021760, 11032121, 11054202, 11061692, 11065332, 11068413, 11087476, 11092084, 11095657, 11117289, 11120886, 11125670, 11136295, 11150676, 11153938, 11157330, 11175379, 11183495, 11187100, 11190386, 11208628, 11211359, 11215867, 11225034, 11257463, 11261004, 11301624, 11315777, 11331624, 11333846, 11349839, 11352808, 11375194, 11378966, 11397734, 11400415, 11425859, 11430776, 11448194, 11451668, 11452871, 11455664, 11473931, 11478628, 11482202, 11502663, 11506259, 11514450, 11518314, 11536951, 11555850, 11560166, 11563841, 11581312, 11585150, 11588552, 11603391, 11607318, 11626199, 11629148, 11632317, 11650606, 11653698, 11658172, 11683821, 11684991, 11690159, 11693994, 11720081, 11723522, 11726262, 11754297, 11759875, 11771875, 11775495, 11790418, 11793861, 11807042, 11808883, 11812197, 11834416, 11840561, 11854505, 11858113, 11874533, 11878883, 11892028, 11895817, 11916396, 11919863, 11922245, 11934979, 11939632, 11954003, 11958207, 11965207, 11983076, 12001707, 12004909, 12022530 and 12033767.  Lots Numbers for UPN M00560071: 9250053, 9253199, 9274922, 9279867, 9287088, 9290056, 9307665, 9312999, 9316758, 9348516, 9351987, 9363466, 9368267, 9382130, 9397996, 9401006, 9429622, 9431373, 9435008, 9455619, 9461328, 9493337, 9496154, 9508560, 9510052, 9531833, 9535769, 9552122, 9565745, 9570253, 9587492, 9589049, 9596109, 9599316, 9613556, 9617014, 9641022, 9673179, 9677504, 9684522, 9696760, 9698268, 9713213, 9718808, 9738217, 9743598, 9756826, 9793613, 9797075, 9813026, 9822793, 9826394, 11009246, 11012401, 11025542, 11028694, 11047245, 11049898, 11073503, 11077497, 11080455, 11099298, 11102577, 11107280, 11110742, 11139525, 11143357, 11161747, 11164974, 11180003, 11197392, 11201257, 11228360, 11238916, 11242523, 11245661, 11250295, 11253892, 11278679, 11284687, 11291615, 11295068, 11308482, 11312283, 11341473, 11343030, 11346396, 11363872, 11366629, 11381378, 11386944, 11409113, 11412987, 11416827, 11430777, 11437348, 11442171, 11467643, 11470657, 11485518, 11488894, 11492574, 11495885, 11509421, 11528339, 11533342, 11547440, 11552151, 11566569, 11570397, 11592124, 11610875, 11614199, 11635571, 11639554, 11643662, 11665274, 11669321, 11672022, 11676512, 11701498, 11704984, 11708130, 11734168, 11738370, 11745073, 11761484, 11764687, 11781627, 11783202, 11799806, 11803572, 11819967, 11824012, 11842065, 11844494, 11859922, 11863225, 11866437, 11883712, 11888148, 11903196, 11907510, 11910637, 11925318, 11928967, 11932560, 11947301, 11950696, 11967330, 11970893, 11986374, 11989126, 11994790, 12009780, 12016332, 12019093, 12044519, 12048303, 12055414 and 12058228.
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution.
  • Description du dispositif
    Gold Probe 7FR Working Length: 300 cm, Probe Tip O.D. 2.3 mm (7Fr), Rx Only. Electrical Connector: Standard. For Single Use Only. Legal Manufacturer, Boston Scientific Corporation, One Boston Scientific Place Natick, MA 01760-1537 USA. Made in USA: 8600 N.W. 41st Street Miami, FL 33166-6202 USA. || The device is indicated for use in transendoscopic electrocautery of visible bleeding and nonbleeding sites in the gastrointestinal tract including the esophagus, stomach, duodenum, and colon.
  • Manufacturer
    Boston Scientific Corporation
Device Recall MICROVASIVE GOLD PROBE
  • Modèle / numéro de série
    Lot Numbers for UPN M00560100: 9261338, 9283882, 9305162, 9327239, 9369045, 9372244, 9412852, 9451457, 9505237, 9521511, 9592459, 9633852, 9681234, 9722306, 9753577, 9754934, 9754935, 9754936, 9810372, 9824002, 11015389, 11036295, 11057651, 11083694, 11147192, 11204692, 11229075, 11263907, 11320518, 11357567, 11390523, 11394227, 11463699, 11525430, 11544096, 11595300, 11617465, 11661744, 11696754, 11742585, 11767910, 11815749, 11871189, 11899606, 11975822, 12027023 and 12051845.  Lot Numbers for UPN M00560101: 9256060, 9356184, 9473937, 9562330, 9644511, 9774420, 11043881, 11132563, 11194002, 11284265, 11324380, 11460248, 11573667, 11624658, 11716593, 11830799, 11979368 and 12030396.
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution.
  • Description du dispositif
    Gold Probe 10FR Working Length: 300 cm, Probe Tip O.D. 3.2 mm (10Fr), Rx Only. Electrical Connector: Standard. For Single Use Only. Legal Manufacturer, Boston Scientific Corporation, One Boston Scientific Place Natick, MA 01760-1537 USA. Made in USA: 8600 N.W. 41st Street Miami, FL 33166-6202 USA. || The device is indicated for use in transendoscopic electrocautery of visible bleeding and nonbleeding sites in the gastrointestinal tract including the esophagus, stomach, duodenum, and colon.
  • Manufacturer
    Boston Scientific Corporation