Cordis Corporation Recalled its Optease Retrievable Inferior Vena Cava (IVC) Filter to correct the label to provide clarification and additional information to minimize the likelihood of implanting the filter backwards. This recall covers 33,000 units distributed in the United States between May 6, 2010, and April 2, 2013.
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.
In addition to instructing customers to read the description and recommendations sections of the Instructions for Use, Cordis is also making corrections and improvements to the device labeling.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
See the Recall