Table of contents
- Latest Optease IVC Filter Lawsuit Updates
- January 2, 2018: Florida Law Firm Sues Cordis over TrapEase Death
- October 27, 2014: FDA Lists OptEase Correction as Terminated
- August 07, 2013: FDA Posts OptEase Correction as Class 1 Recall
- March 29, 2013: Cordis Starts OptEase Labeling Correction
- What Is an IVC Filter?
- Who May Be Affected?
- Reported Injuries or Damages
- Recall and Regulatory Background
- Evidence to Preserve
- Filing Deadlines
- Frequently Asked Questions
- Is There an Optease IVC Filter Lawsuit?
- Was the Optease IVC Filter Recalled?
- What Does the Research Say About IVC Filter Complications?
- What Fracture Rates Does the Optease Lawsuit Cite?
- Were Optease Filters Distributed Outside the United States?
- Who Can I Call About the Optease Filter Recall?
The Cordis Optease IVC filter is named in individual product-liability suits, including one over the TrapEase filter. They allege the filters can fracture, break apart or move through the blood system. One suit also alleges a patient’s death.
In 2013, Cordis Corporation, a Johnson & Johnson company, corrected the OptEase labeling for about 33,000 filters. The FDA classed the action as Class 1 and named labeling design as the cause. The recall record is now terminated.
The suits so far are individual cases in state court, and no MDL names Optease. The newest suit was reported in January 2018, and the FDA recall record closed in 2014.
Latest Optease IVC Filter Lawsuit Updates
January 2, 2018: Florida Law Firm Sues Cordis over TrapEase Death
On January 2, 2018, DAIC reported a Florida law firm’s suit against Cordis in Palm Beach Circuit Court. The suit says the OptEase and TrapEase filters “fail at alarming rates” [1].
It alleges a New Jersey man died from complications of a Cordis TrapEase IVC filter. These are the plaintiff’s allegations, not court findings.
October 27, 2014: FDA Lists OptEase Correction as Terminated
On October 27, 2014, the FDA’s recall database listed the Cordis OptEase correction, number Z-1887-2013, as terminated in its public recall record [2].
August 07, 2013: FDA Posts OptEase Correction as Class 1 Recall
On August 07, 2013, the FDA posted the Cordis OptEase Vena Cava Filter correction in its recall database as a Class 1 recall, number Z-1887-2013.
March 29, 2013: Cordis Starts OptEase Labeling Correction
On March 29, 2013, Cordis Corporation began a correction covering about 33,000 OptEase filters. The correction adds labeling to minimize the chance of implanting the filter backwards.
Cordis sent its notification letter to consignees after that start date. The letter is dated April 3, 2013, and it was titled as an urgent medical device correction.
What Is an IVC Filter?
According to the FDA, an inferior vena cava (IVC) filter is a small cage-like device. It is inserted into the largest vein in the body. It captures blood clots and stops them from traveling to the lungs [3].
The recall record says the Optease filter helps prevent recurrent pulmonary embolism. A doctor places it when anticoagulants cannot be used or have failed. Other uses are massive and chronic recurrent pulmonary embolism.
Who May Be Affected?
People implanted with a Cordis OptEase filter, catalog number 466F220A or 466F220B, may be affected. MassDevice reported that the affected devices were distributed in the U.S. between May 6, 2010 and April 2, 2013 [4].
The man in the reported Palm Beach suit died in March 2016. Individual suits name both the Optease and TrapEase filters, so a patient with either Cordis filter may have similar questions.
Whether you have a claim depends on your own facts, and an individual legal review is the only way to know if you qualify.
Reported Injuries or Damages
The Palm Beach suit alleges the filter broke apart and moved through the blood. It also alleges the inferior vena cava ruptured, citing an autopsy. It says the man died from thrombosis. These are complaint allegations.
The FDA record’s stated problem is labeling, not injuries. MassDevice reported that Class I means the device could cause serious injury or death.
One 2024 study concerned the Cook Celect IVC filter, a different maker’s device. TCTMD reported on December 3, 2024 on the study in Annals of Internal Medicine. Kushal T. Kadakia and colleagues reviewed unsealed court records [5].
FDA reviewers found perforation in 15% of those filters. The company had said its animal studies showed no sign of perforation.
Recall and Regulatory Background
The FDA recall record for the OptEase filter describes a labeling correction made by Cordis. A recall does not by itself establish liability.
Evidence to Preserve
Keep these records and copies of them. They show which filter you got and what came next:
- Product identifiers, such as your implant card, catalog or lot numbers and the operative report
- Medical and imaging records, including scans that show where the filter sits
- Removal or retrieval records, if a doctor tried to take the filter out
- Photographs related to the filter or to any procedure that followed
- Purchase and billing records from the hospital, clinic or insurer
- Messages with your doctor or hospital about the filter
- Notes of your symptoms, with the dates they began and changed
Filing Deadlines
A claim must be filed within a time limit set by state law. The limit can differ a lot from one state to another.
The clock may start on the date of injury. In some places it starts when you learned the filter was the likely cause.
A claim filed too late can be dismissed, however strong the facts. Talk to a lawyer soon about the limits that apply to you.
Frequently Asked Questions
Is There an Optease IVC Filter Lawsuit?
Yes, individual lawsuits over the Optease and TrapEase filters have been filed in state court. Osborne & Associates is the firm behind one. It says the man’s TrapEase filter was implanted in October 2012, and the suit also cites the Optease filter.
Was the Optease IVC Filter Recalled?
Yes, the Optease IVC filter was recalled in a Class 1 correction in 2013. Cordis added labeling to the filter, and the FDA recall record now lists the correction as terminated, which is not a finding of liability.
What Does the Research Say About IVC Filter Complications?
Research on IVC filter complications includes a 2024 study of the Cook Celect filter, a different maker’s device and not Optease. The study’s authors say patients should not have to turn to litigation to get safety information.
What Fracture Rates Does the Optease Lawsuit Cite?
The Optease lawsuit cites fracture rates from two studies. One shows a fracture rate of 23 percent for TrapEase filters after 46 months. Another reports 64 percent after four years. These are the plaintiff’s citations, not findings.
Were Optease Filters Distributed Outside the United States?
Yes, Optease filters were distributed outside the United States. The FDA recall record lists nationwide distribution within the United States and in the countries of Canada and Panama. Ask your doctor or hospital for your implant records.
Who Can I Call About the Optease Filter Recall?
You can call the Cordis Endovascular Medical Information Line at 877-338-4235 about the Optease filter recall. The FDA recall record lists that number in its action section for the correction.