Devices

Device Recall Gelseal

  • Model / Serial
    Product Code 431508, Batch 301509/01, Serial Numbers 0001515180, 0001515181, 0001515182, 0001515183, 0001515184, 0001515185, 0001515186, 0001515187, 0001515188, 0001515189, 0001515190, 0001515191
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed in the state of Michigan (USA), and the countries of United Kingdom, Australia, Poland, and Germany.
  • Product Description
    Gelseal Straight Diameter 8mm Length 15cm. || Vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access.
  • Manufacturer
    Vascutek, Ltd.
  • 1 Event

Manufacturer

Vascutek, Ltd.
  • Manufacturer Address
    Vascutek, Ltd., Newmains Avenue, Inchinnan United Kingdom
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Source
    USFDA

One device with a similar name

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Device Recall Gelseal
  • Model / Serial
    Product Code 433008, Batch 301509/02, Serial Numbers 0001515204, 0001515205, 0001515206, 0001515207, 0001515208, 0001515209, 0001515210, 0001515211, 0001515212, 0001515213, 0001515214, 0001515215
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed in the state of Michigan (USA), and the countries of United Kingdom, Australia, Poland, and Germany.
  • Product Description
    Gelseal Straight Diameter 8mm Length 30cm. || Vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access.
  • Manufacturer
    Vascutek, Ltd.