Events

Safety Alert for GLIDESHEATH SLENDER Introducer Catheter

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Terumo Corporation.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    R1706-254
  • Event Number
    2015DM-0013666
  • Date
    2017-06-27
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=81
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Colombia.
  • Extra notes in the data

Device

GLIDESHEATH SLENDER Introducer Catheter
  • Model / Serial
  • Product Description
    Product description: GLIDESHEATH SLENDER consists of an introducer (a sheath and a dilator), a flexible tip mini guide and a vascular access needle. The surface of the pod of this product is covered with a hydrophilic coating exclusive of TERUMO CORPORATION. When the surface of the sheath is wetted, good lubrication is achieved and the coefficient of deflection is markedly reduced. Description of the components: consult the product label for an appropriate description of the components it contains. All the components that enter the blood vessels are radiopaque. Sheath: incorporates a unidirectional valve and a three-way key connected to a lateral tube. The sheath can be used with catheters of the same diameter in FR, and even with catheters up to 2 FR. Minors without any loss of blood through the unidirectional valve. Dilator: the precise adjustment between the sheath and the dilator allows the simultaneous manipulation of both. Mini-guide: supeelástica guide, this surrounded by a smooth surface hemorepelente avoids the possibility of kinks. Vascular access needle: internal metallic needle and a plastic cannula. Inserter of the guide. Instructions of use: the GLIDESHEAT SLENDER is used to facilitate the placement of a catheter in the radial artery through the skin.
  • Manufacturer
    Terumo Corporation

Manufacturer

Terumo Corporation