Devices

Device Recall Boston Scientific Platinum Plus Guidewire

  • Modèle / numéro de série
    Lot / Batch #: 8507682, 8529860, 9012874, 9249774, 9249775, and 9830636.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN,MO, MS, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, SI, WV, and WY. OUS locations to include: Balkans, Finland, Germany, Great Britain, Hong Kong, Ireland, Israel, Italy, Mexico, Netherlands, Norway, Romania, Saudia Arabia, Spain, Sweden, Switzerland, and United Arab Emirates
  • Description du dispositif
    Boston Scientific Platinum Plus Guidewire. Material No. [outer carton label] H74917531, Catalog # 1753, Material No. [Inner Pouch Label] H74917530. Sterilized with ethylene oxide gas. The Platinum Plus Guidewire has been designed to provide torsional control. The guidewire has a shapeable and highly radiopaque distal platinum tip. Legal Manufacturer: Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, USA.
  • Manufacturer
    Boston Scientific Corporation
  • 1 Event

Fabricant

Boston Scientific Corporation
  • Adresse du fabricant
    Boston Scientific Corporation, 1 Scimed Pl, Maple Grove MN 55311-1565
  • 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

3 dispositifs médicaux avec un nom similaire

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Device Recall Boston Scientific Platinum Plus Guidewire
  • Modèle / numéro de série
    Lot / Batch #: 7908999, 7945613, 7968042, 8002696, 8049604, 8152432, 8181321, 8188798, 8189027, 8260367, 8289723, 8343908, 8350907, 8418323, 8435607, 8506420, 8529856, 8550971, 8584215, 8620500, 8632756, 8632757, 8636509, 8644935, 8656636, 9175918, 9183100, 9200564, 9455621, 9512879, 9521733, 9535932, 9656252, 9747125, 9813152, 11043633, 11122070, 11181968, 11182772, 11194875, 11259816, 11276388, 11328172, 11342423, 11363879, 11518115, 11604154, and 11665770
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN,MO, MS, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, SI, WV, and WY. OUS locations to include: Balkans, Finland, Germany, Great Britain, Hong Kong, Ireland, Israel, Italy, Mexico, Netherlands, Norway, Romania, Saudia Arabia, Spain, Sweden, Switzerland, and United Arab Emirates
  • Description du dispositif
    Boston Scientific Platinum Plus Guidewire. Material No. [outer carton label] H74917511, Catalog # 1751, Material No. [Inner Pouch Label] H74917510. Sterilized with ethylene oxide gas. The Platinum Plus Guidewire has been designed to provide torsional control. The guidewire has a shapeable and highly radiopaque distal platinum tip. Legal Manufacturer: Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, USA.
  • Manufacturer
    Boston Scientific Corporation
Device Recall Boston Scientific Platinum Plus Guidewire
  • Modèle / numéro de série
    Lot / Batch #: 7871050, 7874112, 7901492, 7908998, 7935372, 7942404, 7946750, 7951989, 7979004, 7987978, 8002687, 8002688, 8025772, 8049137, 8056451, 8076852, 8098810, 8100687, 8115174, 8152431, 8181521, 8181914, 8182172, 8188799, 8193187, 8196976, 8199191, 8200479, 8200913, 8250949, 8252697, 8254876, 8260512, 8267344, 8268818, 8276225, 8281144, 8290915, 8334503, 8344727, 8352846, 8355028, 8356527, 8364588, 8410167, 8410168, 8418161, 8436013, 8439527, 8487277, 8494510, 8494814, 8506052, 8517771, 8529765, 8533184, 8547526, 8547528, 8548109, 8563958, 8584214, 8599724, 8620506, 8621310, 8623982, 8624400, 8624593, 8636348, 8636397, 8636409, 8636503, 8641950, 8833124, 8844258, 8856203, 9095461, 9111353, 9115679, 9115681, 9127229, 9157914, 9161086, 9183101, 9183105, 9185694, 9185695, 9188841, 9200553, 9222896, 9255968, 9261438, 9296807, 9297103, 9320040, 9339417, 9339418, 9346642, 9346643, 9368448, 9431674, 9431675, 9431676, 9435282, 9477092, 9478619, 9506755, 9506757, 9506865, 9521490, 9521491, 9521492, 9569394, 9581945, 9581946, 9583721, 9598709, 9603497, 9605899, 9637090, 9640999, 9644150, 9656493, 9656494, 9687546, 9784975, 9804363, 9822697, 11070550, 11099161, 11129198, 11132701, 11181779, 11181961, 11194872, 11204324, 11205127, 11208660, 11210322, 11243379, 11257970, 11258088, 11279186, 11279187, 11304665, 11304666, 11314418, 11314419, 11331413, 11342422, 11364163, 11364164, 11364441, 11364625, 11367614, 11368112, 11381445, 11381446, 11381713, 11400941, 11400942, 11413485, 11416911, 11416912, 11419631, 11421390, 11441801, 11455976, 11466878, 11482433, 11485605, 11491642, 11566831, 11576501, 11576502, 11604153, 11610376, 11610377, 11631997, and 11632322.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN,MO, MS, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, SI, WV, and WY. OUS locations to include: Balkans, Finland, Germany, Great Britain, Hong Kong, Ireland, Israel, Italy, Mexico, Netherlands, Norway, Romania, Saudia Arabia, Spain, Sweden, Switzerland, and United Arab Emirates
  • Description du dispositif
    Boston Scientific Platinum Plus Guidewire. Material No. [outer carton label] H74917521, Catalog # 1752, Material No. [Inner Pouch Label] H74917520. Sterilized with ethylene oxide gas. The Platinum Plus Guidewire has been designed to provide torsional control. The guidewire has a shapeable and highly radiopaque distal platinum tip. Legal Manufacturer: Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, USA.
  • Manufacturer
    Boston Scientific Corporation
Device Recall Boston Scientific Platinum Plus Guidewire
  • Modèle / numéro de série
    Lot / Batch #: 7873372, 7909303, 7987688, 8025769, 8049696, 8202657, 8203318, 8260511, 8289582, 8351041, 8372192, 8372883, 8410171, 8418162, 8432959, 8506417, 8533771, and 11643756.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN,MO, MS, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, SI, WV, and WY. OUS locations to include: Balkans, Finland, Germany, Great Britain, Hong Kong, Ireland, Israel, Italy, Mexico, Netherlands, Norway, Romania, Saudia Arabia, Spain, Sweden, Switzerland, and United Arab Emirates
  • Description du dispositif
    Boston Scientific Platinum Plus Guidewire. Material No. [outer carton label] H74917541, Catalog # 1754, Material No. [Inner Pouch Label] H74917540. Sterilized with ethylene oxide gas. The Platinum Plus Guidewire has been designed to provide torsional control. The guidewire has a shapeable and highly radiopaque distal platinum tip. Legal Manufacturer: Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, USA.
  • Manufacturer
    Boston Scientific Corporation