IVC Filter Complications, Lawsuits and FDA

Inferior vena cava (IVC) filters are small devices that are implanted in the large vein that carries blood from your lower body to your heart. They’re used in patients at risk for pulmonary embolisms who can’t take blood thinners.

While some filters are designed to be temporary, many are left in the body longer than intended. According to the U.S. Food and Drug Administration (FDA), leaving them in for more than a few weeks increases the risk of complications like IVC perforation or migration.

“There are probably over two dozen filter types floating around in the U.S. Some are old, permanent ones that have been discontinued. All the way to the latest ones that have been released,” Dr. William Kuo, Director of the Stanford IVC Filter Clinic, told Drugwatch. The clinic pioneered new methods for removing IVC filters that have been left in the body for extended periods.

Serious Injuries Possible if IVC Filters Remain In for Too Long

The FDA warns that the risk of complications, including filter fracture, filter-associated IVC thrombosis or vein perforation, increases significantly when retrievable filters remain in place for more than 29 to 54 days.

Device fracturing has long been a concern with IVC filters. A 2012 Journal of Interventional Radiology study found that 40% of Bard filters left in place for five and a half years fractured.

“Historically, most filters that have been implanted in the U.S. have not been adequately followed [by doctors] for possible removal,” Dr. Kuo shared.

He warns that if doctors do not follow up with these patients for potential complications or removal, the filters may become stuck for years. This may lead to complications.

“By then, it can be a real challenge to take these filters out,” Dr. Kuo said.

The FDA first advised removing retrievable IVC filters once the pulmonary embolism risk subsides, citing severe complications like migration, fracture and perforation.

In 2014, the FDA issued its recommendation for a maximum implantation time of 29 to 54 days. The agency also required manufacturers to conduct studies, like the PRESERVE study, to address safety concerns regarding filters used in medical procedures.

Thousands of IVC Filters Recalled

Between 2005 and 2015, more than 81,000 IVC filters were recalled. Two of the IVC filter recalls were Class I, which is the most serious designation the FDA can assign to a recall.

A Class I recall was issued for Boston Scientific’s Greenfield filter because parts could separate while being implanted, potentially causing an embolism in the heart or lungs. The recall affected 18,000 units.

Cordis’s OptEase IVC filter ordered a Class I recall because of a labeling error that could cause the filter to be implanted backward. That recall affected 33,000 units.

Attention to complications may have contributed to the decline in the use of IVC filters. In 2013, 44,680 filters were implanted, compared to only 19,501 in 2019.

Thousands of patients have filed lawsuits against IVC filter manufacturers, including C.R. Bard and Cook Medical. These IVC filter lawsuits allege that the devices were defectively designed and caused serious injuries.

Lawsuits against C.R. Bard and Cook Medical were combined into multidistrict litigations (MDLs). An MDL is when several similar lawsuits are consolidated into a single litigation to simplify and expedite the legal process.

As of July 2025, there were 6,978 Cook IVC filter lawsuits pending in MDL 2570 in a southern Indiana federal court.

C.R. Bard entered into negotiations to settle cases against it in an Arizona federal court. As of September 15, 2023, no C.R. Bard IVC filter lawsuits remained in the multidistrict litigation. MDL-2641 closed in July 2024.

Juries delivered verdicts against C.R. Bard and Cook Medical in state courts and bellwether trials. Bellwether trials are test cases that MDLs conduct to determine if plaintiffs have a case that may lead to settlements or dismissals of the MDL lawsuits.

Cook Medical Hid IVC Filter Complications

A 2024 article in the Annals of Internal Medicine found hidden safety concerns and poor testing with Cook Medical’s Celect IVC filter.

Examining unsealed court records, researchers found the device was first denied FDA approval. However, it later received approval through the agency’s 510(k) authorization pathway.

Rather than proving a medical device is safe, a 510(k) allows for approval if the device is substantially similar to one already on the market.

Their court document and public records review revealed that reports of complications and patient deaths submitted to the FDA omitted crucial details. They also found these incidents were wrongly represented in published studies and on the Celect IVC label.

Consequently, patients and health care providers received misleading information about the device’s safety.

If you had an IVC filter implanted, talk to your doctor about if it should be removed. These filters are intended to be temporary. Keeping one in place for too long can lead to serious complications.

If you’re unsure about your filter’s status or you experience nausea, swelling, redness, fever or chest pain afterward implantation, consult your doctor immediately.

If you believe the filter has harmed you, consider speaking with a lawyer who specializes in medical device cases to discuss your options. Drugwatch can connect you with experienced attorneys for free consultations.

Before talking to an attorney, gather your medical records, including all records about the IVC filter procedure and any complications you were treated for following the procedure. Timely action can reduce your health risks and help you understand your rights if a device fails.