The Wall Street Journal reports that closer FDA scrutiny of Guidant's product lines led to yesterday's recall of its Insignia and Nexus pacemaker models. The paper says the problem was uncovered during last week's FDA inspection of the Guidant plant in St. Paul Minnesota. Initial evidence suggests the defects are non-fatal and have led to only a few hospitalizations.
- see this story from The Wall Street Journal (sub. req.)
PLUS: Meanwhile in other medical device news, an investor has launched a shareholder suit against Boston Scientific alleging the company inflated its stock value by withholding word of serious defects with some products. Story