Boston Scientific Stent Recall
The FDA has recalled Boston Scientific Express2TM (bare metal) coronary stent's. The Express2™ stent system consists of a stent (small metal tube) which is mounted on a balloon catheter.
Balloons used to deploy the stent's -- small, wire-mesh tubes inserted into clogged arteries to open them up -- failed to deflate or were so hard to remove that three people died and dozens more were injured during operations performed after the 2004 recall, according to Food and Drug Administration records.
Boston Scientific's Taxus Express stent is the most popular drug-coated stent in the U.S., with about 60% of the market. The Taxus Express was launched in the U.S. in March 2004, and had been in use in Europe before that. Its arch rival is the Cypher stent, made by Johnson & Johnson.
The number of Boston Scientific stent's implanted between Oct. 1 and April 1 couldn't be determined. But the company says 592,676 Taxus Express stent's were sold and more than 700,000 were shipped during those six months. That would suggest a rate of deflation complaints better than one in 10,000 but short of the goal of one in 100,000.
It's possible that the number of reports went up after the recall due to doctor's awareness of the problem. At the time of the recall, Boston Scientific officials said that "given the clinical severity of a no-deflate," it was unlikely that complaints had been underreported.
Of the 45 recent deflation problems reported to the FDA, 43 occurred with the Taxus Express, the most widely used of the two Boston Scientific stent's recalled last year. The others occurred with the Taxus Liberate, a newer model sold outside the U.S. , which wasn't recalled.
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