IVC Filter Products
There are a number of inferior vena cava (IVC) filter manufacturers, but there are a few manufacturers that have marketed retrievable or removable (nonpermanent) filters. The manufacturers with the largest share of retrievable IVC filters are C.R. Bard, Inc. and Bard Peripheral Vascular, Inc. (collectively, Bard) and Cook Incorporated, Cook Medical LLC, and William Cook Europe ApS (collectively, Cook). Additional manufacturers of these devices include Johnson & Johnson, B. Braun Medical, ALN, Rex Medical, and Rafael Medical.
FDA Approval and Warnings
The IVC filters are cleared for use by the U.S. Food and Drug Administration (FDA) after a manufacturer submits a Premarket Notification or 510(k), which notifies the FDA of the intent to market a medical device. Nonpermanent filters are classified as either temporary (i.e., must be removed due to structural features that preclude permanent implantation) or optional (i.e., the same device can be used for either permanent or short-term caval interruption).
On August 9, 2010, the FDA issued an Advisory Letter recommending health care providers consider removing a temporary filter as soon as protection from a PE is no longer needed. On May 6, 2014, the FDA issued another Advisory Letter recommending removal of IVC filters within 29-54 days.
Injured by your IVC filter?
We are investigating injuries which may have been caused by potentially defective filters manufactured by Bard, Cook, and others. Have you or a loved one had a retrievable IVC filter implanted? Has it migrated, fractured, perforated organs, or caused other injuries? Get a free case consultation with our personal injury lawyers by calling toll-free (800) 254-9493 or filling out the form.
Bard Removable IVC Filters
Bard has marketed a several IVC filters as removable. Bard identified three groups who would benefit from retrievable filters to expand their IVC filter market share: bariatric patients, trauma patients, and orthopedic patients. The Bard filters are made of Nitinol, which is a nickel titanium alloy.
- Bard Recovery IVC Filter – 510(k) clearance for retrievable use in July 2003 (withdrawn 2005)
- Bard G2 IVC Filter – 510(k) clearance for retrievable use in January 2008
- Bard G2 Express / G2x Filter – 510(k) clearance for retrievable use in 2008
- Eclipse – 510(k) clearance for retrievable use in January 2010
- Meridian – 510(k) clearance for retrievable use in 2011
- Denali – 510(k) clearance for retrievable use in May 2013
A review of the FDA MAUDE database from the years 2004-2008 revealed data to establish that Bard’s IVC filters were responsible for the following percentages of IVC filter adverse event reports (AERs):
- 50% of all adverse events
- 64% of all occurrences of migration of the device
- 69% of all occurrences of vena cava wall perforation
- 70% of all occurrences of filter fracture
On July 13, 2015, the FDA issued a Warning Letter to C.R. Bard indicating that the Recovery Cone Removal System was never approved or cleared by the FDA and further stated that Bard failed to establish and maintain procedures for reviewing and evaluating complaints regarding the G2, G2x, and Eclipse filters. Bard also failed to report information suggesting its device had malfunctioned or was likely to cause injury or death.
Cook Conichrome Filters
Cook IVC Filters are made from Conichrome, which is a cobalt-chromium-nickel-molybdenum-iron alloy.
- Günther Tulip Vena Cava Filter – 510(k) clearance for retrievable use in October 2003
- Günther Tulip Mreye – 510(k) clearance for retrievable use in October 2003
- Cook Celect Vena Cava Filter – 510(k) clearance for retrievable use in March 2008
- Cook Celect Platinum – 510(k) clearance for retrievable use in July 2012
Johnson & Johnson (Cordis) Optional
- Cordis OptEase – 510(k) clearance for retrievable use in March 2004
- ALN – 510(k) clearance for retrievable use in January 2008
Rex Medical Optional
- Option Vena Cava Filter – 510(k) clearance in June 2009
Rafael (RMT) Medical Optional
- SafeFlo Vena Cava Filter – 510(k) clearance in May 2009
B. Braun Medical Convertible
- Vena Tech – initial 510(k) clearance May 2001
“Greenfield” IVC Filters
IVC filters are sometimes referred to generically as “Greenfield,” but this is a Boston Scientific product typically used for permanent implantation in patients at risk of pulmonary emboli (PE). The Boston Scientific Greenfield Vena Cava Filter received 510(k) clearance in 1990.
Speak to an Injury Lawyer
If you’ve had an IVC filter implanted, our personal injury attorneys are interested in speaking with you. Call toll-free (800) 254-9493 for a free consultation.
Our attorneys have experience representing patients in pharmaceutical and medical device litigation against major manufacturers for allegedly defective drugs and medical devices such as Actos, Yaz, Risperdal, the Mirena IUD, GranuFlo, Eon spinal stimulators, and Medtronic defibrillators.