August 9, 2013 — Cordis Corporation, a subsidiary company of Johnson & Johnson company, has announced a voluntary Class I recall of the Optease Inferior Vena Cava (IVC) filter on concerns that it could be implanted backwards. Cordis notified healthcare providers on March 29 and recalled about 33,000 Optease IVC filters. The filters were distributed in the U.S. from May 6, 2010 until April 2, 2013.
Cordis began warning about the risk on April 3, 2013, when they sent an “URGENT Medical Device Correction” letter to customers. The letter instructed customers to read certain sections of the instructions and return a signed acknowledgement form to Cordis.
Cordis will be recalling the IVC filters to make corrections to the label with clearer instructions and “additional information to minimize the likelihood of implanting the filter backwards,” according to the FDA.
The FDA has designated the recall as “Class I,” which means the FDA believes the problem could lead to serious injury or death. The FDA previously issued warnings for problems with retrievable IVC filters in 2010, after receiving more than 900 reports of adverse events involving Bard IVC filter complications, including:
- traveling to other parts of the body (heart, lungs, etc.)
- perforation the patient’s inferior vena cava
The Optease Retrievable IVC Filter is an egg-shaped wire device that is implanted in patients at risk of a blood clot in their lungs (pulmonary embolism). The filter is placed in the inferior vena cava (IVC), which is the blood vessel between the heart and the lungs. Retrievable IVC filters are temporary implants that are designed to be removed when the patient is no longer at risk of a pulmonary embolism.