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
24001
Event Risk Class
I
Event Initiated Date
2010-05-03
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
Certain cuffed shiley tracheostomy tubes in which the cuff does not hold air as a result of leaks in the pilot balloon inflation assembly.

Device

CIAGLIA BLUE DOLPHIN BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER

Model / Serial
Model Catalog: C-PTBS-2800-PERC8 (Lot serial: G36118); Model Catalog: C-PTBS-2600-PERC6 (Lot serial: G36118); Model Catalog: C-PTBSY-2800-PERC8 (Lot serial: G36116); Model Catalog: C-PTBSY-2600-PERC6 (Lot serial: G36116); Model Catalog: C-PTBS-2800-PERC8 (Lot serial: G36116); Model Catalog: C-PTBS-2600-PERC6 (Lot serial: G36116); Model Catalog: C-PTIS-100-HC-PERC8-CA (Lot serial: G13166); Model Catalog: C-PTIS-100-HC-PERC8 (Lot serial: G13166); Model Catalog: C-PTIS-100-HC-PERC6-CA (Lot serial: G13166); Model Catalog: C-PTIS-100-HC-PERC6 (Lot serial: G13166); Model Catalog: C-PTIS-100-HC-PERC8-CA (Lot serial: G36037); Model Catalog: C-PTIS-100-HC-PERC8 (Lot serial: G36037); Model Catalog: C-PTIS-100-HC-PERC6-CA (Lot serial: G36037); Model Catalog: C-PTIS-100-HC-PERC6 (Lot serial: G36037); Model Catalog: C-PTIS-100-HC-PERC8-CA (Lot serial: G13165); Model Catalog: C-PTIS-100-HC-PERC8 (Lot serial: G13165); Model Catalog: C-PTIS-100-HC-PERC6-CA (Lot serial: G13165); Model Catalog: C-PTIS-100-HC-PERC6 (Lot serial
Product Classification
Anesthesiology Devices
Product Description
ciaglia blue dolphin balloon percutan.
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 CIAGLIA BLUE DOLPHIN BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER

What is this?

Device

CIAGLIA BLUE DOLPHIN BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER

Manufacturer

COOK (CANADA) INC.