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
RC-2014-RN-00166-1
Event Risk Class
Class II
Event Initiated Date
2014-02-26
Event Country
Australia
Event Source
DHTGA
Event Source URL
https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00166-1
Notes / Alerts

Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Extra notes in the data
Reason
Following the report of an edi catheter disintegrating in a patient after 17 days of use maquet has decided to provide the edi catheter with its own user's manual. the edi catheter ifu states that the catheter can only be in use for a maximum of 5 days.
Action
Maquet is advising end users that the instructions for use will be provided with the Edi catheter and reiterating that the device can only be in use for up to 5 days.

Device

Edi Catheter (nasogastric feeding tube)

Model / Serial
Edi Catheter (nasogastric feeding tube)Edi Catheter,6Fr,49cm,PHT free 5pcs/pkgArticle Number: 6685775Edi Catheter, 6Fr, 50cm, PHT free 5pcs/pkgArticle Number: 6685777Edi Catheter,8Fr,100cm,PHT free 5pcs/pkgArticle Number: 6685780Edi Catheter,8Fr,125cm,PHT free 5pcs/pkgArticle Number: 6685782Edi Catheter,12Fr,125cm,PHT free 5pcs/pkgArticle Number: 6685787Edi Catheter,16Fr,125cm,PHT free 5pcs/pkgArticle Number: 6685790
Manufacturer
Maquet Australia Pty Ltd

Manufacturer

Maquet Australia Pty Ltd

Manufacturer Parent Company (2017)
Getinge AB
Source
DHTGA

About this database

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

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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.

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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.

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Recall of Edi Catheter (nasogastric feeding tube)

What is this?

Device

Edi Catheter (nasogastric feeding tube)

Manufacturer

Maquet Australia Pty Ltd