Events

Recall of Device Recall Gelseal

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Vascutek, Ltd..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    71305
  • Event Risk Class
    Class 2
  • Event Number
    Z-1912-2015
  • Event Initiated Date
    2015-05-15
  • Event Date Posted
    2015-06-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-10-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137269
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Graft, vascular, synthetic/biologic composite - Product Code MAL
  • Reason
    Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft.
  • Action
    On 5/15/2015, Vascutek issued a URGENT FIELD SAFETY NOTICE to their consignee informing them of the corrective action of the affected product. The information included details of the affected devices, including potential risks and actions to be taken by medical staff and distributors.

Device

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.

Manufacturer

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