IVC Filter FDA Recalls and Warnings

IVC filters have been the subject of several recalls and warnings issued by the U.S. Food and Drug Administration (FDA). These stern actions taken by the FDA have been in response to data suggesting that IVC filters are plagued with design defects that have caused serious medical problems for those who have had them implanted. Nevertheless, thousands of people have still been hurt by defective IVC filters, forcing them to file IVC filter lawsuits against device makers.

ivc filter fracture

1. What are IVC filters?

An inferior vena cava, or IVC, filter is an implantable medical device. It looks like a badminton shuttlecock that is made out of metal or a fishing lure: Most of them have several legs, or struts, projecting from the head of the device.

IVC filters are indicated for people who are at a high risk of developing blood clots, and who cannot take other medication to prevent clotting. An IVC filter is implanted and navigated into the patient's inferior vena cava vein – the vein that brings blood from the legs to the heart and lungs. In the inferior vena cava, the IVC filter's shape is designed to block blood clots from reaching the lungs, where they could cause a potentially fatal pulmonary embolism.

Once the risk of blood clotting has passed, IVC filters are supposed to be removed.

However, IVC filters carry significant health risks. They have been known to:

These problems have led to the FDA's warnings and recalls.

2. FDA warns the public about the dangers of IVC filters

The FDA has issued two warnings to the public about the dangers associated with IVC filters.

The first warning came in 2010.1 Noting that the use of IVC filters in patients had skyrocketed – up from 2,000 implants in 1979 to 167,000 in 2007 to an estimated 259,000 in 2012 – the FDA mentioned a disturbing accumulation of adverse event reports. Since 2005, the FDA had received 921 of them, including:

  • 328 reports of IVC filters that migrated from their place in the inferior vena cava,
  • 146 reports of embolizations, or pieces of an IVC filter that became detached and moved into the patient's heart or lungs,
  • 70 reports of the IVC filter perforating a patient's inferior vena cava, and
  • 56 reports of the IVC filter fracturing after implant.

The FDA noted that some of these problems could have been caused by the device being left inside the patient for too long, and recommended that physicians remove IVC filters as soon as the risk for pulmonary embolisms had subsided.

The FDA followed up this warning with another one in 2014.2 This new warning stressed the risks of leaving IVC filters in patients for longer than necessary. It also pointed to a medical study that had found that the risks of an IVC filter began to outweigh the benefits between 29 and 54 days after it was implanted.3

The warnings by the FDA spurred IVC filter manufacturers to conduct postmarket clinical trials, including the PRESERVE Study.

3. FDA sends warning letter to C.R. Bard over IVC filters

In 2015, the FDA sent a warning letter to IVC filter manufacturer C.R. Bard.4

The warning letter accused the company of making and selling two IVC filter retrieval devices that had been neither approved nor cleared by the FDA:

  • Recovery Cone Removal System, Model RC-15, and
  • Recovery Cone Removal System, Model FBRC.

Perhaps more importantly, though, the FDA's warning letter accused Bard of failing to properly report IVC device malfunctions that contributed to a death or serious injury in the MAUDE database. Each of these failures drastically understated the severity of the device malfunction in Bard's favor, covering up the dangers of IVC filters.

4. Recalls for IVC filters

The FDA has never issued a mandatory recall of any IVC filter implant. IVC filter manufacturers have made several voluntary recalls of IVC filter models that have been especially dangerous. However, none of those voluntary recalls have gone far enough in removing defective and dangerous products from the market.

The table below provides the IVC filter recall list, updated through May, 2019:

Date Posted

Recall Class

IVC Filter Product

Source of Recall

Reason for Recall

Termination Date

3/19/2019

3

Celect Platinum and Gunther Tulip

Cook Medical

Updates to Instructions for Use

Open

3/13/2015

2

Denali IVC Filter

Bard

Missing information from Instructions for Use

2/1/2016

9/27/2013

2

OptEase Vena Cava Filter

Cordis

Printing error instructed IVC filter to be implanted upside down

9/23/2014

3/29/2013

1

OptEase Vena Cava Filter

Cordis

Labeling could lead to implanting IVC filter backwards

10/27/2014

10/30/2007

2

VenaTech LP Vena Cava Filter System

B. Braun

Package sealing problem could compromise device sterility

3/2/2008

10/6/2006

3

Stainless Steel Greenfield Vena Cava Filter

Boston Scientific

Wrong expiration date

7/3/2012

12/2/2005

1

Greenfield Vena Cava Filter

Boston Scientific

Carrier capsule and outer sheath can detach and cause embolization in the patient's heart or lungs

4/2/2007

8/5/2005

2

Greenfield Vena Cava Filter

Boston Scientific

Some devices may lack a taper on the braided sheath of the filter, which could tear the edge of the vein

11/9/2006


References:

  1. U.S. Food and Drug Administration, “Removing Retrievable Inferior Vena Cava Filters: Initial Communication” (Aug. 9, 2010).

  2. U.S. Food and Drug Administration, “Removing Retrievable Inferior Vena Cava Filters: FDA Safety Communication” (May 6, 2014).

  3. Morales JP, et al., “Decision analysis of retrievable inferior vena cava filters in patients without pulmonary embolism,” Journal of Vascular Surgery 1(4):376-84 (October 2013).

  4. U.S. Food and Drug Administration, “Warning Letter to C.R. Bard, Inc.” (July 13, 2015).

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