NEW YORK (AP) – An analyst says Boston Scientific has suspended all sales of its implantable cardioverter defibrillators after finding a documentation error in regulatory filings.
Bernstein senior analyst Derrick Sung says in a research note the error puts the Natick, Mass., medical device maker’s devices out of compliance with Food and Drug Administration regulations. He also says the error is tied to documentation. It does not appear to be tied to quality or safety concerns.
Boston Scientific spokesman Paul Donovan could not be immediately reached for comment.
The devices shock the heart to restore a regular rhythm. Sung says their sales make up 15 percent of total company revenue.
Date: March 15, 2010
Source: Associated Press