Labelling Correction Prompts “Recall” for Cordis Optease Retrievable Inferior Vena Cava Filter

Cordis and the FDA have notified healthcare professionals and their organizations of a product labeling correction to provide clarification and additional information to minimize likelihood of implanting the company’s Optease Vena Cava filter backwards.

Background

The Optease Retrievable Vena Cava Filter is used for the prevention of recurrent pulmonary embolism in patients under specific situations. The device is implanted into the inferior vena cava and is designed to be retrieved when the patient no longer requires a filter.

This is another of those recalls that isn’t a recall, no product return being demanded. Instead the company shipped out a letter plus new IFU, together with a requirement that customers read the instructions and acknowledge having done so in writing. The issue seems to have been one of language, it not being clear in the original instructions how to avoid inserting the device backwards.

The recall covers 33,000 units distributed in the United States between 05/06/2010 and 04/02/2013.

The full recall notice can be found here.

Source: FDA