Device Recall Boston Scientific

  • Model / Serial
    All lots
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was released for distribution to 38 consignees in US nationwide. International distribution includes EU and Canada. It did not involve Defense Supply Center, VA or other Federal Government sales/distribution centers.
  • Product Description
    Boston Scientific brand Position Acquisition Module (PAM), a component of Realtime Position Management (RPM) System, || Catalog/Model Numbers: 8200010, 8200TWA0
  • Manufacturer
  • 2 Events

Manufacturer

  • Manufacturer Address
    Boston Scientific, 2710 Orchard Pkwy, San Jose CA 95134-2012
  • Source
    USFDA

174 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lot Numbers:  5175575 5185073 5185074 5185075 5193211 5193212 5193213 5193920 5196902
  • Product Classification
  • Distribution
    Nationwide
  • Product Description
    Boston Scientific/Microvasive Rapid Exchange Retrieval Balloon/11.5 mm balloon || Catalog # 4545
  • Manufacturer
  • Model / Serial
    Pouch codes for the 180 cm length wuidewires are:  Catalog No. 46-591, UPN M001465910 Lot Number Use Before Date 4959940 2005-08 4959941 '' 4969651 '' 4969654 '' 4969655 '' 4969656 ''  The pouch codes for the 260 cm length guidewires are: Catalog No. 46-5912, UPN M001465920 Lot Number Use Before Date 4959945 2005-08 4959946 '' 4959944 '' 4959943 ''
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed to 118 hospitals nationwide.
  • Product Description
    Medi-Tech Magic Torque Glidex hydrophilic coated guidewire, .035 inch/180 cm and .035 inch/260 cm lengths. Packaged in a sterile pouch and a three pack shelf box.
  • Manufacturer
  • Model / Serial
    Lot Numbers: 5178407 5202076 5275909 5309468 5337024
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Foreign:Singapore, Japan, Korea, Canada, Africa
  • Product Description
    Boston Scientific/Microvasive Open End Ureteral Catheter (4 Fr x 70 cm) || Product Number: 400-200
  • Manufacturer
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