Devices

Device Recall Boston Scientific

  • Modèle / numéro de série
    Lot Numbers: 7889257, 7892749, 7924670, 7924672, 7944542, 7948443, 7948444, 7959299, 7959300, 7975078, 7975079, 7979468, 7979469, 7991051, 7991054, 7998758, 7998759, 7998760, 8002684, 8002685, 8014025, 8041040, 8041041, 8041222, 8052772, 8052774, 8060259, 8071855, 8071856, 8075138, 8080170, 8093632, 8109650, 8109651, 8114689, 8117678, 8131078, 8151476, 8155398, 8166781, 8170747, 8174687, 8174689, 8187008, 8191493, 8206779, 8206780, 8211778, 8211779, 8214766, 8226828, 8230827, 8230830, 8231159, 8268293, 8272150, 8272151, 8284684, 8284685, 8290955, 8306944, 8319230, 8319231, 8339003, 8339005, 8343275, 8343279, 8347008, 8367859, 8367860, 8367861, 8385775, 8385776, 8385777, 8389894, 8389895, 8401051, 8406650, 8406651, 8406652, 8427648, 8427649, 8431394, 8449739, 84623248, 8466568, 8466569, 8466570, 8474529, 8474530, 8474531, 8482833, 8486629, 8486630, 8486631, 8503298, 8503299, 8503300, 8505352, 8505353, 8505354, 8505355, 8505356, 8505357, 8505358, 8505359, 8505360, 8505361, 8505362, 8505363, 8505364, 8507020, 8511088, 8526132, 8526135, 8547345, 8547346, 8551223, 8551224, 8567704, 8571917, 8571918, 8571919, 8583897, 8583898, 8583899, 8591867, 8611580, 8611581, 8614222, 8648847, 8648849, 8648850, 8655868, 8655869, 8683744, 8688103, 8692109, 8706158, 8709576, 8709923, 8709975, 8724559, 8724560, 8727932, 8727933, 8752575, 8766341, 8766342, 8775286, 8775287, 8810553, 8810554, 8810570, 8814730, 8815105, 8844670, 8844671, 8844872, 8849235, 8849236, 8849237, 8853318, 8853319, 8867181, 8893397, 8898058, 8902082, 8902083, 8913833, 8935976, 8935977, 8935978, 8948215, 8976949, 9132297, 9132373, 9132374, 9132375, 9132376, 9132377, 9132378, 9132379, 9132380, 9132381, 9132382, 9132383, 9132384, 9132385, 9132386, 9132387, 9132388, 9132389
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide distribution --- USA and countries of Austria, Belgium, France, Czech Republic, Germany, great Britain, Greece,Ireland, Italy, Luxemburg, Netherlands, Norway, Poland, Portugal, Spain, Switzerland, and Sweden.
  • Description du dispositif
    Wallstent Endoscopic Biliary Endoprosthesis 10mm x 80mm, UPN H965430600
  • Manufacturer
    Boston Scientific Corporation
  • 1 Event

Fabricant

Boston Scientific Corporation
  • Adresse du fabricant
    Boston Scientific Corporation, One Boston Scientific Place, Natick MA 01760
  • Source
    USFDA

174 dispositifs médicaux avec un nom similaire

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Device Recall Boston Scientific Endovive 20F (6.7 mm) Safety PEG Kit
  • Modèle / numéro de série
    Inner pouch (UPN M00566470) lots 12004380, 12017735, 12039127, 12068485, 12074073, 1209443, 12115001, 12127100 and 12159831   Packaged in outer cartons (UPN M00566471) with lot numbers of 12069493, 12069494, 12112331, 12123598 and 12145424.
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide.
  • Description du dispositif
    Boston Scientific EndoVive 20F (6.7 mm) Safety PEG Kit, Push Method for use with sterile Xylocaine ampule, latex free, sterile, Boston Scientific Corp., Natick, MA; Cat. no./REF 6647, inner pouch UPN M00566470 and outer carton UPN M00566471. || The devices are indicated for providing nutrition directly into the stomach in adult and pediatric patients who are unable to consume nutrition by conventional means.
  • Manufacturer
    Boston Scientific Corp
Device Recall Boston Scientific EndoVive 24F (8 mm) Safety PEG Kit
  • Modèle / numéro de série
    Inner pouch (UPN M00566490) lots 12007899 and 12101506  packaged in outer cartons (UPN M00566491) with lot numbers of 12065904 and 12148450.
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide.
  • Description du dispositif
    Boston Scientific EndoVive 24F (8 mm) Safety PEG Kit, Push Method for use with sterile Xylocaine ampule, latex free, sterile, Boston Scientific Corp., Natick, MA; Cat. no./REF 6649, inner pouch UPN M00566490 and outer carton UPN M00566491. || The devices are indicated for providing nutrition directly into the stomach in adult and pediatric patients who are unable to consume nutrition by conventional means.
  • Manufacturer
    Boston Scientific Corp
Device Recall Boston Scientific 20F (6.7 mm) Safety PEG Kit
  • Modèle / numéro de série
    Inner pouch (UPN M00566530) packaged in outer cartons (UPN M00566531) with lot number 12080466 on both pouches.
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide.
  • Description du dispositif
    Boston Scientific EndoVive 20Fr (6.7 mm) Safety PEG Kit, Push Method, latex free, sterile, Boston Scientific Corp., Natick, MA; Cat. no./REF 6653, inner pouch UPN M00566530 and outer carton UPN M00566531. || The devices are indicated for providing nutrition directly into the stomach in adult and pediatric patients who are unable to consume nutrition by conventional means.
  • Manufacturer
    Boston Scientific Corp
Device Recall Boston Scientific 20F (6.7 mm) Safety PEG Kit
  • Modèle / numéro de série
    Inner pouch (UPN M00566730) lots 12015222, 12015223, 12017140, 12035930, 12037032, 12038621, 12056814, 12074992, 12096466, 12110667, 12111382, 12111566, 12112012, 12113348, 12129137, 12133028, 12133803 and 12133804  packaged in outer cartons (UPN M00566731) with lot numbers of 12065719, 12065900, 12065903, 12088673, 12105251, 12115743, 12119946, 12145423 and 12148447.
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide.
  • Description du dispositif
    Boston Scientific EndoVive 20F (6.7 mm) Safety PEG Kit, Push Method for use with pre-filled lidocaine syringe, latex free, sterile, Boston Scientific Corp., Natick, MA; Cat. no./REF 6673, inner pouch UPN M00566730 and outer carton UPN M00566731. || The devices are indicated for providing nutrition directly into the stomach in adult and pediatric patients who are unable to consume nutrition by conventional means.
  • Manufacturer
    Boston Scientific Corp
Device Recall Boston Scientific Stonetome Stone Removal Device
  • Modèle / numéro de série
    Lot Numbers: 12012906, 12013569 and 12039341.
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide.
  • Description du dispositif
    Boston Scientific Stonetome Stone Removal Device. Triple Lumen Sphincterotome, 5.5 Fr, 20 mm, 11.5 mm, sterile, Boston Scientific Corp., Natick, MA; REF 3511. || The device is used in diagnostic or therapeutic endoscopic retrograde cholangiopancreatography, transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi, to remove stones from the biliary system, and to facilitate injection of contrast medium while occluding the duct with the balloon.
  • Manufacturer
    Boston Scientific Corp
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