Lawsuits against several different inferior vena cava (IVC) filter device manufacturers are now underway. And the U.S. Food and Drug Administration (FDA) receives many adverse event reports from patients injured by blood clot filters. Despite all these lawsuits and reports, there have been surprisingly few IVC filter recalls in recent years. Even more surprising is the fact that most recalled blood clot filters have little to do with product safety.
From January to April 2018, patients filed 500 adverse event reports with the FDA over serious complications from IVC filters. More than 8,000 active IVC filter lawsuits are now underway across the nation. But manufacturers aren’t scrambling to recall faulty blood clot filters over these injuries. In fact, no company’s issued a major IVC filter recall since 2015. Instead, most notices about recalled blood clot filters cite incorrect packaging or labeling problems.
What Led to Seven Recalled IVC Filters Since 2005?
Recall #1: Boston Scientific Greenfield Blood Clot Filters — August 5, 2005
Boston Scientific recalls two lots of Greenfield IVC filters, citing blood vessel damage as a possible side effect.
Recall #2: Boston Scientific Greenfield Blood Clot Filters — December 2, 2005
Boston Scientific’s second recall that year involved 18,000 faulty Greenfield IVC filters. The company warned that a defect could cause detachment between the device’s carrier capsule and outer sheath. If the capsule detached during placement, patients were at increased risk for cardiac and pulmonary embolization.
Recall #3: C.R. Bard G2 Blood Clot Filters — December 20, 2006
Bard’s first device recall involved 5,761 faulty G2 IVC filters. The company took action after receiving three complaints about sheath tip damage that caused problems for surgeons during insertion. These damaged tips made clot filters more likely to fracture after placement and potentially harm patients.
Recall #4: B. Braun VenaTech Blood Clot Filters — October 30, 2007
Device manufacturer Braun stated that a packing error affecting 60 VenaTech filters likely compromised their quality. “Sterility (packaging integrity) compromised: package sealing problem leaving packaging being partially open…” In other words, the unsealed packaging meant that doctors could unwittingly implant unsterilized devices in patients’ bodies.
Recall #5: Cordis OptEase Blood Clot Filters — March 29, 2013
Nearly six years later, device manufacturer Cordis recalled 33,000 OptEase filters over labeling design flaws. “Correction to provide clarification and additional labeling to minimize likelihood on implanting filter backwards,” reads Cordis’ recall statement.
Recall #6: Cordis OptEase Blood Clot Filters — September 27, 2013
Later that same year, Cordis pulled another 29,395 mis-labeled OptEase filters off the market. The company stated that “the orientation arrow for the femoral approach was printed in the incorrect direction.” This led doctors to implant the filter upside down, making the device’s safe removal especially difficult.
Recall #7: C.R. Bard Recovery Blood Clot Filters — July 2015
A March 2015 FDA warning letter prompted Bard to recall 1,183 affected IVC filters in July 2015. While inspecting the Bard manufacturing facility, the FDA found several marketing and misbranding violations. As a result, Bard recalled over one thousand IVC filters simply because the labels didn’t include warnings.
Why Recent Recalls Failed Patients With Temporary Filters
These recalls look minimal compared to patients reporting life-threatening injuries from blood clot filters. The two manufacturers with the most complaints, Bard and Cook Medical, issued zero recalls for product safety reasons. As a result, thousands of patients still have defective IVC implants in their bodies. What’s worse is that most patients don’t know the FDA recommends removing these filters within 60 days. This timeline helps patients avoid serious (or even fatal) internal puncture wounds.
How To Check Your Eligibility for Compensation
If you or a loved one suffered internal puncture wounds from a temporary inferior vena cava filter, you may qualify for compensation. To check your eligibility for a cash settlement, fill out your free online IVC filter claim evaluation today. Answer just three questions online to confirm your claim’s eligibility for compensation before deciding to move forward. Once you’ve submitted your information, a lawyer will call to discuss how to get the justice and compensation you deserve.
Related: Clot Filters Cost Patients More Money for No Benefits, Says Study
Mandy Voisin is a freelance writer, blogger, and author of Girls of the Ocean and Star of Deliverance. As an accomplished content marketing consultant, mom of four and doctor's wife, Mandy has written hundreds of articles about dangerous drugs and medical devices, medical issues that impact disabled Americans, veterans' healthcare and workers' compensation issues since 2016.