FDA Wants More Data From Boston Scientific

A day after Boston Scientific Corp. (BSX) expanded a month-old recall of a lucrative drug-coated heart stent (search), federal regulators on Friday asked the company for additional data about the manufacturing defect that led to the recall, a company spokesman said.

Food and Drug Administration (search) officials also asked Boston Scientific executives to return next week to Washington for another meeting, after the agency reviews the new information, said Paul Donovan, a company spokesman.

"No (FDA) action was indicated, at least at this time," said Donovan, who characterized Friday's meeting as "frank and honest."

The FDA planned to brief reporters about the situation Friday afternoon.

The meeting came a day after Natick-based Boston Scientific announced it was again expanding the recall. The move covers 3,000 Taxus stents that were not included in the initial nationwide recall of 200 units announced on July 2 and 85,000 others recalled July 16.

Boston Scientific said it determined through its own monitoring that the 3,000 additional stents should have been included earlier in the recall because they may have the same potentially dangerous manufacturing defect that prompted the others to be recalled.

The problem involves a balloon used to expand the metal-mesh stents into place in a clogged artery during surgery called angioplasty. In some cases, the balloon has failed to properly deflate, making it hard to remove from the body and causing the potential for injury or even death.

Boston Scientific shares, which closed down nearly 7 percent Thursday on news of the expanded recall, fell another 2 percent, or 69 cents, to close at $33.21 Friday on the New York Stock Exchange.