All Brands of IVC Filters FDA Approval Dates and Images

Approved IVC Filter Products
United States Food and Drug Administration

07/05/2016: The following images and descriptions are believed to be all of the IVC Filter Products approved by the United States Food and Drug Administration for use in the United States between 1976 (first approved IVC Filter through 2016.)

 

 

Mobin Uddin IVC Filter

 MOBIN-UDDIN VENA CAVA IVC Filter

FDA Approval: 510k  K760152    

07/19/1976
EDWARDS LABORATORIES
4221 Richmond Rd., N.W.
Walker,  MI  49534

Greenfield Stainless Steel IVC Filter Greenfield Stainless Steel IVC Filter
 

Stainless Steel Greenfield IVC Filter

FDA Appoval: 510K K852097

05/15/1985

MEDI-TECH, INC.
480 Plesant St.
P.O. Box 7407
Watertown, MA 02272
BOSTON SCIENTIFIC CORP.
480 Pleasant St.
P.O. Box 7407
Watertown, MA 02272

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IVC Filter Litigation

Titanium Greenfield IVC Filter

FDA Appoval: 510k K870729 

04/09/1987

MEDI-TECH, INC.
480 Plesant St.
P.O. Box 7407
Watertown, MA  02272
BOSTON SCIENTIFIC CORP.
480 Pleasant St.
P.O. Box 7407
Watertown,  MA  02272

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IVC Filter Litigation

Vena Tech LGM IVC Filter Cook Birdsnest IVC Filter

Vena Tech LGM IVC Filter

FDA Appoval: 510k K881604

03/10/1989

Vena Tech IVC Filter
VENA-TECH, INC.
1152 Beacon St.
Brookline, MA 02164
B BRAUN
2934 Central Street, Suite 1a
Evanston, IL 60201

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Cook Medical Birds Nest IVC Filter

FDA Appoval: PMA P850049

04/26/1989

FDA Appoval: 510k K073528 02/27/2008

COOK INCORPORATED
750 Daniels Way
P.O. Box 489
Bloomington, IN 47402 -0489

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Bard Simon Nitinol IVC Filter Cordis TrapEase IVC Filter

Bard Simon Nitinol IVC Filter

FDA Appoval: 510k K894703

4/20/1990

NITINOL MEDICAL TECHNOLOGIES, INC.
7779 Willow Glen Rd.
Los Angles, CA 90046 -1610
BARD PERIPHERAL VASCULAR, INC.
1415 West 3rd St.
Tempe, AZ 85281

(Upon Belief Bard Continues to Distribute this product in the U.S.)

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Cordis TrapEase IVC Filter

FDA Appoval: 510(K) K000062

07/07/2000

CORDIS CORP
7 Powder Horn Dr.
Warren, NJ 07059
JOHNSON & JOHNSON CO.
6500 Paseo Padre Parkway
Fremont, CA 94555

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Cook Gunter Tulip IVC Filter 2000 VenaTech LP IVC Filter

Cook Gunther Tulip IVC Filter

FDA Approval: K00085

10/18/2000

COOK, INC.
925 South Curry Pike
P.O. Box 489
Bloomington, IN 47402

 

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Vena Tech LP IVC Filter

FDA Appoval: 510k K010485

05/18/2001

VENA-TECH, INC.
1152 Beacon St.
Brookline, MA 02164
B BRAUN
2934 Central Street, Suite 1a
Evanston, IL 60201

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Cordis OptEase IVC Filter Bard Recovery IVC Filter

Cordis OptEase IVC Filter

FDA Approval: 510k K023116  

10/18/2002

CORDIS CORP.
7 Powder Horn Dr.
Warren, NJ 07059
CORDIS, A JOHNSON & JOHNSON CO.
6500 Paseo Padre Parkway
Fremont, CA 94555

 

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Bard Recovery IVC Filter 

FDA Approval: 510k K022236

11/27/2002

C.R. BARD, INC.
1625 West 3rd St.
Tempe, AZ 85281 -2438
This product is no longer manufactured
or distributed in the US

( Upon belief, Bard discontinued this product in the US in 2008)

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Bard G2 IVC Filter Cook Plaitnum Celect IVC Filter

Bard G2 IVC Filter 

FDA Approval: 510k K052578

11/25/2005
BARD PERIPHERAL VASCULAR, INC.
1415 West 3rd St.
Tempe, AZ 85281

No longer manufactured
or distributed in the US

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Cook Platinum Celect IVC Filter

FDA Approval: 510k K061815

04/20/2007
COOK CELECT IVC FILTER
WILLIAM COOK EUROPE APS
750 Daniels Way
P.O. Box 489
Bloomington, IN 47402 -0489

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ALN IVC Filter

ALN Optional IVC Filter

 Bard G2 Express IVC Filter

ALN Optional IVC Filter 

FDA Approval: K070514

01/30/2008

ALN IMPLANTS CHIRURGICAUX
900 Circle 75 Pkwy.
Suite 1240
Atlanta, GA 30339

 

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 Bard g2 Express IVC Filter

FDA Approval: 510k K080668       

07/30/2008

C.R. BARD, INC.
1625 West 3rd St.
Tempe, AZ 85281 -2438

No longer manufactured
or distributed in the US

The modification G2 Express was to add a hook to the tip of the filter.

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Rafael Medical Safeflo IVC Filter 2009 Option Elite IVC Filter

 SafeFlo IVC Filter

FDA Approval: 510k K081138  

05/07/09

Rafael Medical Technologies Ltd.
1835 Market Street
Suite 200
Philadelphia, PA 19103

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 Rex Medical Optional Elite

FDA Approval: 510k K081410

06/04/2009

Device Name OPTION VENA CAVA FILTER
REX MEDICAL
386 W. Main Street
Suite 7
Northborough, MA 01532

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Bard Eclipse IVC Filter
 

Bard Merdian IVC Filter
 

Bard Eclipse IVC Filter

FDA Approval: K101431 

06/25/2010

C.R. BARD, INC.
1625 West 3rd St.
Tempe, AZ 85281 -1740

No longer manufactured
or distributed in the US

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Bard Meridian IVC Filter

FDA Approval 510k K102511 

08/24/2011

C.R. BARD, INC.
1625 West 3rd St.
Tempe, AZ 85281 -2438

No longer manufactured
or distributed in the US

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Crux IVC Filter
 
Bard Denali IVC Filter

Crux IVC Filter

FDA Approval: 510k K120402

07/13/2012

Volcano Corporation
3721 Valley Centre Dr., Suite 500
San Diego, CA 92130
CRUX BIOMEDICAL
1455 Adams Drive, #1170
Menlo Park, CA 94025

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Bard Denali IVC Filter

FDA Approval: 510k K130366  

05/15/2013

C.R. BARD, INC.
1625 West 3rd St.
Tempe, AZ 85281

Upon belief this product continues to be marketed in the US.

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Vena Tech Convertible IVC Filter

Vena Tech Convertible IVC Filter

FDA Approval: 510k K152765

02/26/2016

B.BRAUN
824 Twelfth Avenue
Bethlehem, PA 18018

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IVC Filters Not Approved

United States Food and Drug Administration

Braile IVC Filter Aegisy IVC Filter

 Braile IVC Filter 

Braile Biomedica
Oliveira, 1505
Jardim Panorama, São José do Rio Preto
SP, 15092-415, Brasil

 Aegisy IVC Filter

Merit Medical Systems Inc
Salt Lake City, UT
1600 West Merit Parkway
South Jordan UT 84095

Merit Medical Systems entered into a
nonexclusive agreement with Cordis Corp
(see Cordis Trapease Filter)

Amplantz IVC FIlter Antheor IVC Filter

 Amplantz IVC FIlter

Microvena Corp
1861 Buerkle Rd
White Bear Lake, Minnesota 55110

No longer Manufactured

or Distributed

Not available for sale in the US.

 

 Antheor IVC Filter

The maximum duration of the Antheor is 2 week.

Not available for sale in the US.

 

Venti Vidi IVC Filter
 
Tempofilter IVC Filter

Veniti Vidi IVC Filter

VENITI, Inc.
1610 Des Peres Rd., Suite 385
St. Louis, MO 63131

Not available for sale in the US.

 

 

 

 

 

Tempofilter IVC Filter 

B. Braun Melsungen AG
Sieversufer 8
12359 Berlin
Germany

 Designed to be effective for up to 3 months.

Not available for sale in the US.

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FDA Warns Public about Dangerous IVC Filter Side Effects

Bard Denali IVC Filter 2013
Bard Denali IVC Filter 2013

In a public safety communication, the U.S. Food and Drug Administration (FDA) says it has received approximately 920 adverse event reports related to the use of IVC filters, It issued a public report to inform medical professionals and patients about the potential risks associated with using the small, cage-like device. Adverse events reported by the FDA include:

  • Filter fracturing of the device
  • Migration of the pieces
  • Embolization of fractured device or device components
  • Tearing of the inferior vena cava vein.

Cordis IVC Filter Litigation is consolidated in California State Court. Bard IVC Filter Litigation is consolidated in MDL 2641. Cook Medical IVC Filter Litigation is consolidated in MDL 2570.

There is no MDL for Boston Scientific Corp IVC Filter Litigation. “We believe it is possible that more cases will be filed and a motion for consolidation and transfer may be formed in an effort to form an MDL,” said Mass Tort Consultant John Ray.

According to one of the many product liability cases filed against IVC Filter manufacturers:

“Defendants knew or should have known that its Cook Filter when used as expected and intended, had the possibility of shifting, breaking free its implantation site, migrating, perforating the vena cava, and causing serious injury and/or death to patients.”

The case is Olenda Homes et al. v. Cook Medical Inc. et al. (Case No. 5:16-cv-00066).

Patients who cannot use traditional blood-thinning drugs are usually the typical users of IVC filters. The devices are surgically implanted into a patient’s inferior vena cava vein and are designed to catch blood clots from the legs before they migrate to the heart and lungs, which could cause a pulmonary embolism if it reached these important organs. The filters are meant to only be used temporarily, according to the FDA, and hold the clot until it naturally disappears and until the threat of blood clots is no longer an issue.

IVC filters have come under more intense scrutiny and have been the subject of many lawsuits due to allegations that they have fractured with pieces subsequently migrating away from the original insertion point to other parts of the body. The pieces can tear veins and organs, and embed in other “high risk” areas of the body where they cannot be surgically removed, thus causing significant and long-term risks for the patient.

In its report, the FDA identifies a number of potential symptoms of migrating pieces that patients should be on guard for that include out of the ordinary heart rhythms, dizziness, fainting, heart palpitations, and chest pain.

 

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Judge Campbell Pushes Bard IVC Filter Litigation Forward in Arizona

bard-ivc-filter-lawsuit-2Issuing several orders about discovery and trial dates, US District Judge Dennis G. Campbell is pushing forward C.R. Bard IVC Filter Litigation in MDL 2641 consolidated in Arizona federal court.

Product liability and injury lawsuits filed against Bard, Cordis and other retrievable IVC filter makers allege that these companies knew or should have known that the devices were defective because:

  • The defendants failed to conduct appropriate testing, including human clinical testing, to determine how the devices actually functioned in the body.
  • Published medical studies have found many complications including fracture, device migration, perforation of the vena cava wall, organ penetration, and increased risk for venous thrombosis.
  • The defendants misrepresented the risks with retrievable ICVs and failed to issue appropriate safety warnings to patients and physicians.

At least 27 deaths have been associated with Bard’s Recovery filter — a spider-shaped apparatus that is inserted into the largest vein in the body — over the course of a decade. Government data shows about 300 other non-fatal problems have also been reported with the Recovery.

Even as death and injury reports were climbing, the company decided not to recall the Recovery. Instead, Bard sold about 34,000 of them for nearly three years before replacing them with a modified version with a new name, G2.

Discovery schedule

Following the fourth Case Management Conference, the court set time, place and manner limitations on depositions. In one order on June 21, the court said, “Any Federal Rule of Civil Procedure and/or Local Rule purporting to limit the number of depositions shall not apply in this MDL proceeding. If either side believes that the other is taking unnecessary or irrelevant depositions they may bring the issue to the Court for appropriate resolution.”

In a second order on June 21, Judge Campbell reaffirmed the October 28, 2016 fact discovery deadline. He said he will consolidate a recently-filed a medical monitoring class action, Barraza, et al. v. CR Bard, Inc., et al., Case No. CV-16-1374-PHX-DGC (D. Ariz. May 5, 2016).

The next Case Management Conference on August 23, 2016 in Phoenix.

The FDA issued a warning letter one year ago citing Bard with a number of violations and their failure to warn of complications from their IVC filter. It charged that:

  • The company misfiled consumer complaints, including a death, and manufactured its Recovery Cone Removal System Model RC-15 without first receiving marketing clearance or approval, which violates federal law.
  • Bard failed to tell the FDA about medical device malfunctions, and filing complaints as malfunctions that should have been filed as serious injuries.
  • Until the company correct the violations, the FDA will not clear or approve any premarket submissions for high-risk Class III medical devices “to which the non-conformances are reasonably related.”

Cases set for trial

The court also set several cases for trial:

  • By June 29, 2016, the parties will exchange of lists identifying 24 representative cases each selected from the Initial Plaintiff Pool. Those 48 cases will constitute Discovery Group 1.
  • By December 9, 2016, the parties will exchange lists of 10 cases selected from Group 1. The parties can each designate 4 cases on those lists for automatic inclusion in Discovery Group 1. After exchange of lists, the parties will confer to name the remaining 4 additional cases that will be included in Discovery Group 1.
  • By December 16, 2016, the parties will complete submit a list of twelve 12 cases they jointly recommend as Discovery Group 1.
  • By March 1, 2017, the parties will exchange lists of 6 proposed selections from Discovery Group 1 for bellwether plaintiffs. The parties will confer to agree upon a group of 6 cases to constitute Bellwether Group 1.
  • After this group is confirmed, trial dates will be set.

 

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