Device Recall Mach 1 Guide Catheter

  • Model / Serial
    Batch / Lot #: 687877, 687878, 687879, 688002
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Boston Scientific Mach 1 Peripheral Guide Catheter, 6F, 55cm, LIMA Tip Shape, UPN # M001196620, Catalog # 19-662. Made in Mexico: Edificio G1 Local B, H, Parque Industrial La Mesa, Tijuana, Baja California 22650 MEX.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Boston Scientific, 1 Scimed Pl, Maple Grove MN 55311-1565
  • Source
    USFDA

7 devices with a similar name

Learn more about the data here

  • Model / Serial
    Batch / Lot # 687532
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Boston Scientific Mach 1 Guide Catheter Femoral Approach, 6F, 0.070'', Internal Mammary Curve, UPN # H74934356260, Catalog # 34356-26. Made in Mexico: Edificio G1 Local B, H, Parque Industrial La Mesa, Tijuana, Baja California 22650 MEX.
  • Manufacturer
  • Model / Serial
    Batch / Lot #: 687586, 687593, 687596
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Boston Scientific Mach 1 Guide Catheter Femoral Approach, 6F, 0.070'', Voda Left Curve, UPN # H74934356710, Catalog # 34356-71. Made in Mexico: Edificio G1 Local B, H, Parque Industrial La Mesa, Tijuana, Baja California 22650 MEX.
  • Manufacturer
  • Model / Serial
    Batch / Lot # 687654
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Boston Scientific Mach 1 Guide Catheter Femoral Approach, 7F, 0.081'', Multipurpose Curve, UPN # H74934357380, Catalog # 34357-38. Made in Mexico: Edificio G1 Local B, H, Parque Industrial La Mesa, Tijuana, Baja California 22650 MEX.
  • Manufacturer
  • Model / Serial
    Batch / Lot # 687753
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Boston Scientific Mach 1 Guide Catheter Femoral Approach, 8F, 0.091'', Amplatz Right Curve, UPN # H74934358180, Catalog # 34358-18. Made in Mexico: Edificio G1 Local B, H, Parque Industrial La Mesa, Tijuana, Baja California 22650 MEX.
  • Manufacturer
  • Model / Serial
    Batch / Lot # 687754
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Boston Scientific Mach 1 Guide Catheter Femoral Approach, 8F, 0.091'', Amplatz Left Curve, UPN # H74934358190, Catalog # 34358-19. Made in Mexico: Edificio G1 Local B, H, Parque Industrial La Mesa, Tijuana, Baja California 22650 MEX.
  • Manufacturer
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