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Health Canada Issues Safety Warning for IVC Filters

Health Canada Issues Safety Warning for IVC Filters

July 26, 2016 — Health Canada is warning about serious safety risks associated with IVC filters after receiving a number of adverse event reports.

The agency received 121 reports as of June 6, with many involving long-term use for at least 30 days. The reported side effects include:

  • Vena cava perforation
  • Blood clots
  • Fractured filters and embolization of broken pieces
  • Migration to the heart
  • Perforation of the heart
  • Cardiac tamponade
  • Death

Health Canada is asking hospitals to identify all patients who have received a temporary IVC filter and create a plan have them assessed for filter removal.

The agency is also reminding doctors that IVC filters should only be used in patients who cannot take blood-thinning medications and have been diagnosed with acute pulmonary embolism (PE) or deep vein thrombosis (DVT) in the legs.

There have been only two randomized controlled studies of IVC filter safety, and neither study showed a reduced risk of death or venous thromboembolism, according to Health Canada.

In the United States, over 1,500 people have already filed lawsuits against C.R. Bard and Cook Medical for downplaying the risks associated with IVC filters. The FDA issued a warning in 2010 after receiving nearly 950 adverse event reports.

Products affected
IVC FilterCategoryManufacturer
ALN Vena Cava FilterRetrievableA.L.N
Denali Vena Cava FilterRetrievableBard Peripheral Vascular
G2 Filter SystemRetrievable
Simon Nitinol Vena Cava FilterPermanent
VenaTech LP Vena Cava Filter SystemPermanentB. Braun Medical
Optease Vena Cava FilterRetrievableCordis Cashel
Trapease Permanent Vena Cava FilterPermanent
Option Retrievable Vena Cava Filter SystemRetrievableREX Medical, LP
Cook Celect Platinum Vena Cava FilterRetrievableWilliam Cook, Europe APS And Cook, Inc.
Cook Celect Vena Cava FilterRetrievable
Gianturco-Roehm Birds Nest Vena Cava FilterPermanent
Gunther Tulip Vena Cava MREye Filter SetRetrievable

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