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Study: Cook IVC Filter Shows 43 Percent Risk of Perforation

Illustration of human body and Cook IVC Filters

A new study reveals a brand of IVC filter — a small, metal cage-like device used to prevent blood clots from entering the lungs — poses a significant risk of puncturing a major blood vessel.

The Cook Celect filter had a 43 percent rate of perforation versus the Option filter, which had a zero percent perforation rate. Study authors noted this was a “significantly higher rate.”

In the study published in June 2015 in the Journal of Vascular Interventional Radiology, researchers looked at the records of 99 people implanted with the Cook Celect IVC filter and 86 patients who received an Option filter sold by Rex Medical. After about two months, doctors retrieved the filters. While surgeons had slightly more difficulty retrieving Option filters from the vein, the difference in the rate of retrieval was negligible.

Researchers were more concerned with a potentially troublesome complication: vena cava perforation. Surgeons place IVC filters in the inferior vena cava, the large vein that carries blood back to the heart. The filters are designed with small prongs called struts that act like a cage for blood clots. Unfortunately, some devices also puncture, or perforate, the vena cava wall.

Cook Faces Federal Lawsuits

Results of the study add to growing concerns about Cook’s IVC filter safety.

Injured by complications related to an IVC filter? Get a Free Case Review

The company faces more than 100 lawsuits in federal multidistrict litigation in the Southern District of Indiana before Judge Richard L. Young. Plaintiffs in the litigation claim Cook’s filters fractured, causing serious harm and even death. Legal experts say more lawsuits could follow.

The Cook filters named in lawsuits include Celect and Gunther Tulip.

The U.S. Food and Drug Administration first issued a warning for IVC filters in 2010. The agency said filters may fracture and move throughout the body, perforating blood vessels and organs. In 2014, the FDA updated the warning, adding retrievable filters should be removed within two months of implantation.

C.R. Bard May Have Known of Risks

Cook is not the only manufacturer facing lawsuits. C.R. Bard is also named in about 50 cases involving its Recovery, G2 and G2 Express filters.

In 2015, NBC News investigated C.R. Bard and found the company knew about the troubles with its filters as early as 2002. The FDA originally refused to grant the devices clearance and Bard hired Kay Fuller, a regulatory specialist, to help move the process along. Based on clinical data, Fuller refused to sign the clearance application. According to her, the application was signed without her knowledge and submitted to the FDA.

In 2012, Bard’s attorneys accidentally leaked a confidential document called the Lehmann report in the middle of a lawsuit. Dr. John Lehmann, a doctor hired as a consultant,  wrote the report in 2004 and detailed the problems with Bard’s filters. His study found they had higher complication rates than other filters.

Bard requested all copies of the report be destroyed. While a California state court denied the request, the report is barred from being used as evidence in other cases in many states.

Michelle Llamas, Senior Content Writer
Written By Michelle Llamas Senior Writer

Michelle Llamas has been writing articles and producing podcasts about drugs, medical devices and the FDA for seven years. She specializes in fluoroquinolone antibiotics and products that affect women’s health such as Essure birth control, transvaginal mesh and talcum powder. Michelle collaborates with experts, including board-certified doctors, patients and advocates, to provide trusted health information to the public. Some of her qualifications include:

  • American Medical Writers Association (AMWA) Engage Committee and Membership Committee member
  • Centers for Disease Control and Prevention (CDC) Health Literacy certificates
  • Original works published or cited in The Lancet, British Journal of Clinical Pharmacology and the Journal for Palliative Medicine

4 Cited Research Articles writers follow rigorous sourcing guidelines and cite only trustworthy sources of information, including peer-reviewed journals, court records, academic organizations, highly regarded nonprofit organizations, government reports and interviews with qualified experts. Review our editorial policy to learn more about our process for producing accurate, current and balanced content.

  1. Ryu, R.K. et al. (2015) A comparison of retrievability: Celect versus Option filter. Journal of Vascular Interventional Radiology. Retrieved from:
  2. Lehmann, J. (2004, December 15). Evaluation of MAUDE reporting rates, sales estimates and comparative bench testing related to vena cava filters. Retrieved from:
  3. U.S. Food and Drug Administration. (2014, May 6). Removing retrievable inferior vena cava filters: FDA safety communication. Retrieved from:
  4. Sandler, T. Naggiar, S., & Gosik, S. (2015, September 3). Did blood-clot filter used on thousands of Americans have fatal flaw? Retrieved from:
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