International Medical Devices Database

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
32784
Event Risk Class
II
Event Initiated Date
2015-12-18
Event Country
Canada
Event Source
HC
Notes / Alerts

Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Extra notes in the data
Reason
There is a risk the joint may separate during deployment. a failure of this joint would represent a device malfunction and were it to occur during a procedure may result in a partial stent deployment. the clinical effect of a partial deployment may be a need for surgical intervention or may result in vessel trauma or an embolic event.

Device

ZILVER 518RX VASCULAR STENT RAPID EXCHANGE SELF-EXPANDING STENT

Model / Serial
Model Catalog: ZIVX5-18-125-7-30 (Lot serial: C930162); Model Catalog: ZIVX5-18-125-7-20 (Lot serial: C930162); Model Catalog: ZIVX5-18-125-9-40 (Lot serial: C912967); Model Catalog: ZIVX5-18-125-8-30 (Lot serial: C912967); Model Catalog: ZIVX5-18-125-6-20 (Lot serial: C912967); Model Catalog: ZIVX5-18-125-7-30 (Lot serial: C912967); Model Catalog: ZIVX5-18-125-7-20 (Lot serial: C912967); Model Catalog: ZIVX5-18-125-9-40 (Lot serial: C974746); Model Catalog: ZIVX5-18-125-8-30 (Lot serial: C974746); Model Catalog: ZIVX5-18-125-6-20 (Lot serial: C974746); Model Catalog: ZIVX5-18-125-7-30 (Lot serial: C974746); Model Catalog: ZIVX5-18-125-7-20 (Lot serial: C974746); Model Catalog: ZIVX5-18-125-9-40 (Lot serial: C967899); Model Catalog: ZIVX5-18-125-8-30 (Lot serial: C967899); Model Catalog: ZIVX5-18-125-6-20 (Lot serial: C967899); Model Catalog: ZIVX5-18-125-7-30 (Lot serial: C967899); Model Catalog: ZIVX5-18-125-7-20 (Lot serial: C967899); Model Catalog: ZIVX5-18-125-9-40 (Lot serial: C939544); Model Catalog:
Product Description
ZILVER 518RX VASCULAR STENT RAPID EXCHANGE SELF-E
Manufacturer
COOK (CANADA) INC.

Manufacturer

COOK (CANADA) INC.

Manufacturer Address
STOUFFVILLE
Manufacturer Parent Company (2017)
Cook Group Incorporated
Source
HC

About this database

Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

Stories in your inbox

Do you work in the medical industry? Or have experience with a medical device? Our reporting is not done yet. We want to hear from you.

Tell us your story!

Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

Download the data

The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

Download all (zipped)

Recall of ZILVER 518RX VASCULAR STENT RAPID EXCHANGE SELF-EXPANDING STENT

What is this?

Device

ZILVER 518RX VASCULAR STENT RAPID EXCHANGE SELF-EXPANDING STENT

Manufacturer

COOK (CANADA) INC.