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Cordis Corporation is recalling about 33,000 Optease inferior vena cava (IVC) filters due to labeling problems that may cause surgeons to implant them backwards in patients, posing a serious injury risk.
After Cordis sent an “URGENT Medical Device Correction” letter to customers in the U.S. and Canada to provide updated label information, the FDA determined this week that the action constitutes a Cordis Optease Retrievable IVC filter recall.
The FDA has designated the letter as a class I medical device recall, which means that the agency believes that it is highly possible that the labeling problem could lead to serious injury or death for a patient.
The letter Cordis sent out four months ago provided a labeling correction that was designed to provide doctors clarification and additional information on implanting the Optease IVC filter to prevent backwards implantation.
The recall affects the Optease Retrievable Vena Cava Filter, distributed in the U.S. between May 6, 2010, and April 2, 2013.
IVC Filter Problems
Inferior vena cava filters are an alternative treatment for patients at risk for a pulmonary embolism. They are often used when an anticoagulant is contraindicated or if such medications have not been effective. They contain a number of legs or struts that extend out like a spider to catch blood clots that may break free elsewhere in the body, such as the deep veins of the legs.
In August 2010, the FDA issued an alert warning about the risk of problems with retrievable IVC filters, indicating the agency had received more than 900 adverse event reports associated with the products.
The Cordis Optease IVC filter and other similar products are designed so that they can be removed once the risk of a pulmonary embolism has passed. In the prior FDA alert, the agency indicated that doctors should remove the filters once the danger of the clot has passed, to reduce the risk of the filters breaking free. If there is an IVC filter strut fracture, small pieces of the filter may travel to other parts of the body, such as the heart or lungs.
Of the 921 adverse event reports described in the 2010 FDA warning, the agency indicated that 328 involved the IVC filter breaking free and migrating through the body, 146 involved components breaking loose, 70 involved the inferior vena cava being perforated and 56 involved the filter fracturing.
C.R. Bard faces a number of IVC filter lawsuits over its Bard Recovery and Bard G2 filters, which allege that the medical device maker knew or should have known that their filters were prone to fracture and cause severe complications, but failed to adequately warn doctors or patients.
Customers or consumers with questions about the Optease IVC filter recall can call the Cordis Endovascular Medical Information Center at (877) 338-4235 or write an e-mail to email@example.com.