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
15555
Event Initiated Date
2013-10-22
Event Country
New Zealand
Event Source
NZMMDSA
Event Source URL
https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
Notes / Alerts

Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
Extra notes in the data

Recalling Organisation: Johnson & Johnson Medical New Zealand Ltd, 507 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
Reason
A printing error has been identified on one unit of optease® retrievable vena cava filter. the orientation arrow for the femoral approach was printed in the incorrect direction. the error resulted in the filter being implanted upside down, requiring an additional percutaneous procedure to retrieve the filter. all lots of the cordis optease® retrievable vena cava filter are being removed, since it cannot be absolutely determined that no other similar printing errors occurred.
Action
Product to be returned to supplier

Device

Cordis OPTEASE Retreivable Vena Cava Filter

Model / Serial
Model: Product Code: 466F210A, Affected: All lots below lot number 15960131
Product Classification
Cardiovascular Devices
Manufacturer
Cordis Cashel

Manufacturer

Cordis Cashel

Manufacturer Parent Company (2017)
Cardinal Health
Source
NZMMDSA

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 Cordis OPTEASE Retreivable Vena Cava Filter

What is this?

Device

Cordis OPTEASE Retreivable Vena Cava Filter

Manufacturer

Cordis Cashel