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FDA Seeks More Boston Scientific Data

Aug 6, 2004 | AP

A day after Boston Scientific Corp. expanded a month-old recall of its lucrative drug-coated heart stent, federal regulators met Friday with company officials and asked for additional data about the manufacturing defect that led to the recall.

The Food and Drug Administration also said it plans to inspect a stent manufacturing plant in Ireland. The examination would be similar to one last month at a Minnesota plant where the agency found no serious problems that could have contributed to the defect.

After meeting with Boston Scientific officials in Washington, the FDA's top medical devices regulator said he did not immediately see a need to widen the recall beyond the nearly 100,000 Taxus and Express 2 model stents already recalled.

"The preliminary indication is that these quality assurance measures are adequate to ensure the safety of the product," Dr. Daniel Schultz said in a conference call.

The agency will review new data Boston Scientific will share and may request a second meeting in person or by phone as early as next week, Schultz said. Among those attending Friday's meeting were Boston Scientific's chief executive James Tobin and Dennis Ocwieja, the company's top regulatory affairs executive.

Schultz also said the agency saw no need to take any action on another 100,000 to 200,000 Boston Scientific stents produced before April and May, when the company adopted manufacturing changes aimed at preventing the defect. Those stents have been shipped or await delivery, but are not believed to have the defect that led to the recall.

Friday's meeting came a day after the Natick-based company announced it was again expanding its stent recall. The move covered 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 that the 3,000 additional stents should have been included in the earlier recall because they may have the same problem that prompted the others to be recalled.

The expanded recall was ordered because the company discovered an inspection problem at a factory in Galway, Ireland involving stents produced in late April, company spokesman Paul Donovan said. The FDA inspection will be of the Galway facility.

The defect 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. The defect has been associated with three deaths as well as 47 serious injuries.

Boston Scientific shares closed down 69 cents, or 2.4 percent, at $33.21 Friday on the New York Stock Exchange, adding to a nearly 7 percent slide the day before.

The company's stock price is nearly $10 below its close on July 1, the day before the initial recall was announced.

In addition to about 88,000 Taxus stents, the recall covers 11,000 Express 2 bare-metal stents that are not coated with the slow-release drug that the Taxus model uses to help prevent build-up of post-surgical scar tissue that can cause new blockages. The Taxus was first introduced in February 2003 in Europe and approved for U.S. use in March.

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