Boston Scientific recalls heart stents

Boston Scientific Corp, a device maker that has recalled 99,200 heart stents in the past month, has adequate quality-control measures in place, the US Food and Drug Administration said.
Boston Scientific recalls heart stents

The company met with agency officials yesterday to discuss its voluntary recall of stents, tiny mesh tubes used to prop open arteries, because of manufacturing defects linked to at least one death and 22 injuries. The FDA requested more data and will meet with the company this week to discuss the recall, which was expanded yesterday to include another 3,000 devices.

“At this time, it would be unwise to institute any further recall,” said Dan Schultz, head of the FDA division that regulates medical devices.

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