August 9, 2013 — Cordis Corporation, a Johnson & Johnson company, is recalling Optease Inferior Vena Cava (IVC) filters. The company is concerned that the instructions are not clear enough and healthcare providers could implant the Optease IVC filter backwards. The recall affects about 33,000 filters distributed from May 2010 until April 2013.
Cordis initiated the recall by sending an “URGENT Medical Device Correction” letter to customers on April 3, 2013. The company made corrections and clarifications on the instructions.
According to the FDA, the letter provided “additional information to minimize the likelihood of implanting the filter backwards.” Cordis instructed customers to read the new instructions, sign an acknowledgment form, and return it to the company.
The FDA has classified the recall as a Class I, meaning that the problem could cause severe injury or death.
In 2010, the FDA published a Safety Alert about life-threatening adverse events that can occur when retrievable IVC filters are not removed after the patient is not at risk of a pulmonary embolism. The FDA received over 900 reports of IVC filter complications, including:
- migrating
- getting stuck in a patient’s heart or lungs
- fracturing
- perforating the inferior vena cava
The Cordis Optease is an egg-shaped wire device that is implanted in a blood vessel called the inferior vena cava, which separates the heart and lungs. The filter is designed to catch blood clots before they enter the lungs and cause a pulmonary embolism.
Do I have an IVC Filter Lawsuit?
The Schmidt Firm, PLLC is evaluating IVC filter cases in all 50 states, regardless of whether you were injured or not. If you or someone you know received an IVC filter implant, please contact our lawyers immediately for a free case consultation. You may be entitled to compensation by filing a lawsuit.
Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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