Events

Safety Alert for Reusable Handles with Sharp Tips Used with the Medtronic AneuRx Stent-Graft System (Tapered-Tip Reusable Handles used with Medtronic AneuRx Stent-Graft Systems Catalog Nos .: (1) YRBR2012135, (2) YRBR2012165, (3) YRBR2213135, (4) YRBR2213165, (5) YRBR2414135, (6) YRBR2414165, (7) YRBR2615135, (8) YRBR2615165, (9) YRBR2816135, (10) YRBR2816165, (11) YRBR3116135, (12) YRBR3116165, (1) PD03138-20, (2) PD03139-20, (15) YREC22375, (16) YREC24375, (17) YREC26375, (18) YREC28375, (19) YREC31375, (3) PD03138-22, (4) PD03139-22, (5) PD03138-24, (6) PD03139-24, (7) PD03138-26, (8) PD03139-26, (9) PD03138-28, 10) PD03139-28, (11 to 13, 19) Unidentified, (14) PD03140-20, (15) PD03140-22, (16) PD03140-24, (17) PD03140-26, (18) PD03140-28 )

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Medtronic Inc.

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
    649
  • Date
    2000-06-13
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Extra notes in the data
    01/30/2002 - The company informs that STENT VASCULAR PERIFERICO VASCUCOIL was not imported by Medtronic Comercial Ltda, or by any other authorized distributor, and consequently there is no unit of this product in Brazil.
  • Reason
    The aforementioned sharp-tip reusable handles can be detached from the stent-graft catheter system. the distributor initiated a mailing removal dated june 13, 2000.
  • Action
    Make sure that you have received the June 13, 2000 correspondence from Medtronic AVE. Identify and collect any affected product from your inventory. For product return information, please contact your Medtronic AVE representative or mail to the address listed above.

Device

Reusable Handles with Sharp Tips Used with the Medtronic AneuRx Stent-Graft System (Tapered-Tip R...

Manufacturer

Medtronic Inc
  • Source
    ANVSANVISA