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Health Canada Health products

Inferior Vena Cava (IVC) Filters - Risk of Serious Complications

Issued July 25, 2016
Issue
As of June 6, 2016, Health Canada has received 121 incident reports of serious complications associated with IVC filters. Serious complications such as caval perforation, caval thrombosis, filter fracture and fragment embolization, intracardiac migration, cardiac perforation, cardiac tamponade, and death have been reported in patients who have been implanted with IVC filters. Many of these complications occurred with long-term (greater than 30 days) filter implantation. These complications have also been reported internationally. Products affected IVC Filter Category Manufacturer ALN Vena Cava Filter Retrievable A.L.N Denali Vena Cava Filter Retrievable Bard Peripheral Vascular G2 Filter System Retrievable Simon Nitinol Vena Cava Filter Permanent VenaTech LP Vena Cava Filter System Permanent B. Braun Medical Optease Vena Cava Filter Retrievable Cordis Cashel Trapease Permanent Vena Cava Filter Permanent Option Retrievable Vena Cava Filter System Retrievable REX Medical, LP Cook Celect Platinum Vena Cava Filter Retrievable William Cook, Europe APS And Cook, Inc. Cook Celect Vena Cava Filter Retrievable Gianturco-Roehm Birds Nest Vena Cava Filter Permanent Gunther Tulip Vena Cava MREye Filter Set Retrievable