What IVC filters are recalled?
The FDA has issued three Class I recalls of IVC filters – the Cordis OPTEASE filter, the Cordis OPTEASE filter introduction kit, and the Greenfield filter system. There are three FDA Class II recalls of IVC filters – the Bard Denali, the Greenfield, and the Cordis OPTEASE filters.
Can a Greenfield filter be removed?
According to the FDA and Radiological Society of North America IVC filters should be removed once the danger of a life-threatening clot is over. Although the procedure to remove the filter is also minimally-invasive, removing the device may be challenging especially after prolonged dwell times.
Are vena cava filters safe?
IVC filters have been considered reasonably safe mainly because hundreds of thousands have been placed without large safety signals emerging. However, a retrospective review of 952 patients after IVCF placement suggested a 1% rate of serious complications from IVCF.
Who makes Greenfield IVC filters?
Boston Scientific Corp
Table 2
| Name | Manufacturer | FDA approval year/Miscellaneous |
|---|---|---|
| Titanium Greenfield IVC Filter | Boston Scientific Corp Watertown, MA, USA | 1987 |
| Vena Tech LGM IVC Filter | B Braun Evanston, IL, USA | |
| 1989 | ||
| Cook Medical Birds Nest IVC Filter | Cook Incorporated Bloomington, IN, USA | 1989/indicated for inferior vena cava diameters of >28mm |
Are there any problems with the Greenfield vena cava filter?
Greenfield Vena Cava Complications. According to the manufacturer’s website, potential adverse events most commonly associated with Greenfield vena cava filters include: Procedural complications associated with most IVC filters include access site complications, malposition and defective device deployment.
When did Boston Scientific recall vena cava filters?
In December 2005, Boston Scientific initiated a voluntary recall of all Stainless Steel Greenfield Vena Cava Filters with 12Fr Femoral Introducer Systems manufactured before March 10, 2004. Unused filters with a “use before date” before March 2007 should be returned to the manufacturer.
Are there any recalls on Cook Medical IVC filters?
Cook Medical has not recalled its IVC filters, even with reports of problems. Boston Scientific was the first company to recall IVC filters. The company issued two Greenfield IVC filter recalls in 2005 for patient risks. Why have some IVC filters been recalled?
Who are the manufacturers of the IVC filters?
Most of the lawsuits were over IVC filters that manufacturers never recalled. Among the manufacturers that have issued recalls are Boston Scientific, B. Braun, Cordis and Bard. Cook Medical has not recalled its IVC filters, even with reports of problems. Boston Scientific was the first company to recall IVC filters.
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