The Federal Drug Administration (FDA) has recalled inferior vena cava (IVC) filters of multiple manufacturers because of side effects and complications. The purpose of IVC filters is to prevent blood clots from traveling from the lower body into the heart or lungs and causing pulmonary embolism.
The devices should not be used prophylactically. In other words, the surgeon should not implant an IVC filter in a patient who has not experienced a previous embolism. Also, the devices should only be an option for patients at high risk of recurrent embolism because they cannot take anticoagulant medications or the drugs are not effective for them.
When an IVC filter fails, or there are complications, the patient can suffer devastating or fatal consequences. There are FDA recalls of some of these medical devices. Manufacturers have stopped making some models, replacing some with updated versions.
Classifications of FDA Recalls
The FDA has issued recalls of seven IVC filters from four medical device companies. The recalls include Class I, Class II, and Class III designations, according to the perceived level of danger.
- Class I FDA recalls concern dangerous or defective products that the FDA says could cause severe health problems or death.
- Class II FDA recalls either pose only a slight threat of a significant nature or could lead to a temporary health problem.
- Class III FDA recalls are for products that violate FDA manufacturing or labeling laws but are not likely to cause adverse medical problems.
FDA Recalls of IVC Filters
The FDA has issued three Class I recalls of IVC filters – the Cordis OPTEASE filter, the Cordis OPTEASE filter introduction kit, and the Greenfield filter system. There are three FDA Class II recalls of IVC filters – the Bard Denali, the Greenfield, and the Cordis OPTEASE filters. There is a Class III FDA recall of the Gunther Tulip filter.
Class I Recalls of the Cordis OPTEASE Filter and the Filter's Introduction Kit
Cordis Corporation initiated a recall of its OPTEASE (also called OptEase) Retrieval Inferior Vena Cava filter and its introduction kit on March 29, 2013, after learning of the likelihood of surgeons implanting the devices backwards. Cordis planned to provide additional labeling with greater clarification to minimize the chance of that adverse outcome. There were 33,000 units in the market at the time of the recall.
Class I Recall of the Greenfield IVC Filter System
Boston Scientific Scimed initiated a recall of its Greenfield IVC filter system on December 2, 2005, because they received reports of systems made before March 10, 2004, detaching at the bond between the outer sheath of the filter and the carrier capsule used during implantation. This event creates a risk of pulmonary and cardiac embolization.
There were 18,000 units in commerce at the time of the recall.
Class II Recall of the Bard Denali Filters
Bard Peripheral Vascular Inc. initiated a recall of its Bard Denali Filter-Jugular/Subclavian and Bard Denali Filter-Femoral Delivery on March 13, 2015, because the company wanted to change the label to include warnings that patients who have uncontrolled sepsis or known hypersensitivity to nickel-titanium alloys should not have the device implanted.
There were 1,183 units on the market at the time of the recall.
Class II Recall of the Greenfield Filter
Boston Scientific Scimed initiated a recall of two lot numbers of its Greenfield Vena Cava Filter on August 5, 2005, when it was discovered that some units within 11 lots had a defect that could tear the vein in which the surgeon implanted the device.
The FDA recall notice does not reveal the number of units that were in commerce at the time of the recall, but the company distributed the devices worldwide.
Class II Recall of the Cordis OPTEASE Filter
Cordis initiated a recall of its OPTEASE Vena Cava Filter on September 27, 2013, to correct a printing error that involved an arrow in the implantation instructions being in the wrong direction. As a result of the error, a surgeon implanted a filter upside down, then had to perform an additional surgical procedure to retrieve the filter. Cordis recalled all the units that contained the printing error to correct the labeling and printed instructions.
There were 29,395 units in commerce at the time of the recall.
Class III Recall of the Gunther Tulip Filter
Cook Medical Incorporated initiated a recall of its Gunther Tulip Vena Cava Filter Sets on February 25, 2019, to change the labeling and instructions for use. The FDA recall notice does not reveal why Cook Medical needs to correct the labels and instructions for use, but Cook sent an Urgent Medical Device Correction notification letter to all known customers.
There were 91,731 units in the market at the time of the recall.
What to Do About Injury or Death from a Defective IVC Filter
You should get emergency medical care immediately for a complication or device failure involving an IVC filter. After getting treatment for the medical issues, you should talk with an IVC filter injury lawyer about how to get compensation for your losses.
Failed IVC filters can cause lifelong impairment or fatal consequences. If you have suffered injury or a close relative died because of an IVC filter, the IVC blood clot filter lawsuit lawyers at Tosi & Rose can help. You might be entitled to money damages for your medical bills, lost wages, loss of support, loss of companionship and guidance, pain and suffering, and loss of consortium.
We handle these cases on a contingent fee basis, which means that you will not have to pay us upfront legal fees. Our fees come out of the settlement or award at the end.
Call us today at 888-311-8292 for a free, no-obligation consultation.