Boston Scientific makes stents. “Stents are tiny wire-mesh tubes used to prop open heart arteries after fatty deposits have been cleared away. The devices are inserted through blood vessels and deployed by a tiny balloon that is inflated, pushing the stent in place.” The company has had a problem with its Taxus line of stents, and did a voluntary recall this year.
An article in a frecent edition of the Wall Street Journal reported data from the FDA that at least 45 cases where it was reported that there were difficulties with balloon deflation and 86 cases in which balloons became stuck and were difficult to remove from patients. The problems resulted in three deaths and several injuries, the paper reported.
The FDA plans to take no action.
Read more here.
I have a couple friends who have some of these cases. They can’t give me any specifics – they are wrapped up in a protective order – but the first of the cases goes to trial this fall. I will keep you updated.