There have been lawsuits filed relating to Cook’s IVC filters, as well as other brands of filters, for quite some time. With that litigation comes media attention that ebbs and flows. We expect there may be renewed media attention on this subject, and want to provide our perspective.
Cook stands behind its IVC filters that have saved thousands of lives and are critical to patient well-being. We are committed to continuing the fight for physician and patient access to this important technology and ensure patients have access to this critical tool in the fight against pulmonary embolism.
For decades, Cook has provided lifesaving medical devices to physicians and patients across the globe. Cook’s IVC filters are part of that portfolio of products. Patients needing an IVC filter are at risk of suffering from deadly pulmonary embolism (“PE”), and their doctor has determined that anticoagulants, or anticoagulants alone, cannot prevent the risk of PE.
These patients are often very ill, and IVC filters are essential and lifesaving for the patients that need them.
IVC filters save lives
Pulmonary embolism is the third most common cause of cardiovascular death in the United States. Every year, about 1 in 1,000 Americans will experience a PE, resulting in approximately 100,000 deaths. (American Lung Association; AHA Scientific Statement 2025.) PE occurs when a blood clot travels to an individual’s lung from somewhere else in the body and blocks blood flow. IVC filters are a crucial tool in helping reduce the risk of PE for certain at-risk individuals. An IVC filter is a small metal device that a physician places in a patient’s inferior vena cava to stop blood clots from traveling from the lower body to the lungs.
IVC filters are often placed in patients at risk for PE who either cannot take blood-thinning medications (anticoagulants) or continue to experience blood clots despite taking blood-thinning medications. IVC filters are designed with a conical shape to maximize clot-trapping efficiency while maintaining normal blood flow through the inferior vena cava (“IVC”), which is the largest vein in the body. The IVC carries deoxygenated blood from the abdomen, pelvis, and legs up to the heart where blood is pumped out to a patient’s lungs.
The IVC is a soft, flexible vein that constantly changes shape and size continuously with every breath and depends on patient fluid levels. A conical design resists flattening or sealing off of the vein, which would result in obstruction of blood flow. The design challenge for any IVC filter is keeping blood flowing freely inside a vein that is always moving and changing shape.
Whether an individual is an appropriate candidate for an IVC filter placement is a decision made by the patient’s doctor.
How FDA regulates IVC filters
FDA regulates and oversees the use of IVC filters in the United States. An IVC filter may not be sold in the United States without FDA’s permission. Cook’s IVC filters are no exception, and FDA cleared multiple Cook IVC filters for use in patients, including (1) the Günther Tulip (cleared for permanent indication in 2000 and retrievable indication in October 2003); (2) the Celect (cleared for permanent indication in July 2007 and retrievable indication in March 2008); and (3) the Celect Platinum (cleared for both permanent and retrievable indication in July 2012).
Cook IVC filters have been continuously used by physicians for decades to prevent pulmonary embolism in thousands of patients. There have been no FDA-initiated or voluntary recalls of any Cook IVC filter design. Doctors choose the Cook Tulip and Celect Platinum filters today to treat at-risk patients
What large-scale studies show
Cook supports discussion among physicians within the medical community about the risks and benefits of IVC filters. There are over one hundred published, peer-reviewed papers that include Cook Medical IVC filters.
The results of Cook’s IVC filters in large-scale studies speak for themselves. FDA oversaw a massive, multi-center PRESERVE study (Predicting the Safety and Effectiveness of Inferior Vena Cava Filters) involving filters from numerous manufacturers, including Cook, which was published in 2023. The PRESERVE study tracked 1,421 patients across over 50 U.S. medical centers using filters from one of six manufacturers, including roughly 300 filters made by Cook. PRESERVE was a coordinated effort by the Society for Vascular Surgery, the Society of Interventional Radiology, and the U.S. Food and Drug Administration and concluded that IVC filters are safe and effective in preventing clinically significant pulmonary embolism. (Johnson 2023; SIR and SVS 2023.)
Cook also conducted a major study that followed 473 patients at 28 hospitals around the world, evaluating the long-term safety, effectiveness, and removal rates of its filters. The results, published in the Journal of Vascular and Interventional Radiology in 2025, supported the safety and effectiveness of the filters. Importantly, multiple systematic literature reviews and meta-analyses have found Cook IVC filters to have among the lowest reported rates of breakthrough PE— a pulmonary embolism that happens even though a filter is in place (Angel 2011, Table 3; Jia 2018, Table 1), and a large study by the British Society of Interventional Radiology reported that Cook’s Tulip and Celect filters had among the lowest overall complication rates of any IVC filter on the market (Uberoi 2013, Fig. 4).
Information from these and other large-scale studies including Cook IVC filters proves their safety. Moreover, the United States Food and Drug Administration has evaluated and cleared Cook IVC filters for use in patients multiple times over many years, and FDA has never suggested Cook IVC filters are ineffective or should be withdrawn from the market.
Potential risks and complications
As with any implantable medical device or medical procedure, Cook’s IVC filters have potential risks. Both FDA and the medical community recognized the risk of complications with all IVC filters (not just Cook IVC filters) in 1999, including perforation/penetration, tilt, fracture, and migration. (FDA Guidance 1999 – Guidance for Cardiovascular Intravascular Filter 510(k) Submissions – Guidance for Industry and FDA Staff | FDA; Grassi 2001.)
Physicians weigh the potential risks of IVC filters against IVC filters’ known, lifesaving benefits prior to placement. For patients in need of an IVC filter, the risk of death and other significant complications from pulmonary emboli may outweigh the risks inherent with all IVC filters. This is the treating physician’s key role: using medical judgment, the treating physician must determine whether an individual patient is an appropriate candidate for IVC filter placement.
In appropriately selected patients, Cook’s IVC filters reduce the risk of PE. Multiple systematic literature reviews and meta-analyses have found that Cook IVC filters have among the lowest reported rates of “breakthrough” PE—that is, an episode of PE while an IVC filter is in place. (Angel 2011, Table 3; Jia 2018, Table 1.) What’s more, Cook’s IVC filters accomplish this reduction with low complication rates. A large study by the British Society of Interventional Radiology reported that Cook’s Tulip and Celect filters had among the lowest overall complication rates of any IVC filter on the market. (Uberoi 2013, Fig. 4.)
A note on “perforation”
Perforation is a radiological phenomenon, or something that can be seen on an imaging scan, that may or may not involve penetration through the caval wall, or wall of the vein. FDA has noted that the “[d]etermination of caval penetration is complicated” and that, while “[e]xamination via cavography may show filter hooks or legs outside the flow of contrast[, t]his is not necessarily due to penetration.” (FDA Guidance 1999.)
In fact, a filter needs to anchor into the vein wall to work safely — much like a tent stake has to go into the ground to hold. A filter that doesn’t seat firmly could drift out of position. IVC filters are designed to capture blood clots in a dynamic vein. A filter must sufficiently seat itself in the patient’s inferior vena cava to prevent migration or to keep the filter from moving or being carried away in the bloodstream.
About ongoing litigation
As a result of a significant attorney advertising campaign, multiple manufacturers of IVC filters (e.g., Bard, B. Braun, Boston Scientific, Cordis, and others) have been the subject of litigation. Importantly, an attorney advertisement or lawsuit is not a product recall or safety finding. Cook stands by the safety of its IVC filters and has defended the litigation for over a decade. The mere fact that there is ongoing litigation, however, does not mean that Cook’s IVC filters are defective. On the contrary, many of the plaintiffs’ treating physicians in the litigation have credited Cook’s IVC filters with saving the lives of their patients.
Cook takes seriously every report of a patient experiencing a health issue. Cook actively monitors patient reports of complications, and it meets all applicable regulatory reporting obligations. Cook IVC filters have very low complication rates that are equivalent to or less than other IVC filter designs (Uberoi 2013, Fig. 4.). Cook encourages patients who experience complications with an IVC filter to consult with their physicians about any questions or concerns.
Our commitment
Thousands of physicians have chosen Cook filters to treat their patients for decades. Physicians and the FDA monitor the published literature on medical devices, and they are in the best position to evaluate the safety and efficacy of IVC filters. Any debate about the risks and benefits of medical devices should be left to physicians and the FDA, and Cook supports that scientific and medical discussion.
Cook has defended its IVC filters for more than a decade because we are committed to this lifesaving technology — and to making sure doctors can choose the products best suited to each patient’s needs.