Quality & Patient Safety

Australia: Ventracor device banned after three deaths worldwide

Patient Safety Monitor: Global Edition, March 3, 2009

Ventracor's VentrAssist, an implant used to treat heart failure, will be banned worldwide after the deaths of three patients whose heart pumps failed after its leads were damaged, according to The Australian. This particular model of VentrAssist is used to treat heart failure and has been implanted in 188 patients worldwide. It is currently being investigated by the Therapeutic Goods Administration.

Although the death of the first patient occurred in April 2008, investors in the company said they did not learn about any safety concerns until February 10, 2009, when the second patient died. Ventracor had known about the patient deaths and safety concerns, but failed to inform the public of the complications, according to The Australian.

David Blake, an independent healthcare industry analyst told The Australian that "it appears that Ventracor may have misled the market by not properly disclosing some pretty serious issues relating to its product."

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