Cordis Optease IVC Filter Recall Lawsuit Information
If you or a loved one suffered an injury from a Cordis Optease IVC filter, you may be entitled to money compensation. Call us now for a free consultation at 1-800-321-4477.
The U.S. Food & Drug Administration (FDA) has issued a Class I recall for the Cordis Optease Inferior Vena Cava (IVC) filter. This is a egged shaped wire medical device that is used to catch blood clots leaving the heart before they reach the lungs. This wire filter, implanted in the blood vessel known as the Inferior Vena Cava, is meant to prevent clots in the lungs known as pulmonary embolisms. The Optease IVC filter is manufactured by the Cordis Corporation, a subsidiary of the Johnson and Johnson Company.
What You Need To Know About The Recall
The FDA considers a Class I recall very important. A Class I recall is defined as a recall of a medical device or pharmaceutical that can cause extensive harm to the patient or even death if used in its current condition. This recall impacts approximately 33,000 Cordis Optease IVC filter devices that were issued between May 2010 and April 2013.
Cordis became concerned about the Optease IVC filter when it realized that the instruction pamphlet that is included with their product does not provide clear enough instructions on how to properly implant the device. It is their belief that the instructions can cause medical professionals to insert the filter into the patient backwards and we have seen evidence that doctors have in fact implanted the device improperly because of the faulty instructions written by Cordis.
On April 3, 2013, Cordis sent an “URGENT medical device correction” notice to all medical professionals stating the problem with the instructions and has since corrected the issue by revising their pamphlet. In fact, Cordis made it mandatory that all medical professionals using this IVC filter must read the new pamphlet’s instructions in its entirety and sign a form stating that they read the pamphlet and must also return the signed form to Cordis.
When an IVC filter malfunctions, patients may be at risk of sustaining serious, potentially fatal injuries, including severe and chronic pain in the chest or heart, pulmonary embolism, respiratory problems and death.
The IVC Filter Problem
In 2010, the Food and Drug Administration issued a safety alert on IVC filters, which included the Cordis Optease Filter. These filters, which are considered removable or retrievable when no longer necessary, were not being removed. After receiving over 900 adverse reaction reports, the FDA issued a safety alert warning doctors about the device.
The problems associated with non-removal of the device in a timely manner included:
- The device would fracture and cause problems within the blood vessel.
- Device was migrating into the heart or lungs.
- Device was becoming lodged into the heat or lungs.
- The device was perforating the blood vessel.
- Death from any or all of these actions.
In addition to these problems, the FDA added the following risks and side effects to the device when they issued the Safety Alert.
- Deep vein thrombosis.
- Blood clots clogging the filter.
- Fluid around the heart ( hemorrhagic pericardial effusion)
- Air embolisms.
- Edema in the lower legs.
These side effects are very serious. The FDA further stated in their Alert that doctors should very carefully consider using this device at all. However, if a doctor decides that the device is necessary, the doctor is encouraged to remove it as soon as it is clinically possible. If you or someone you know has suffered injury after an IVC Filter implant, you may be entitled to compensation. Contact our team of experienced medical device litigation attorneys for a free consultation by calling 1-800-321-4477 or by using the contact form provided.