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After patient death, Boston Scientific recalls filter

Dec 3, 2005 | Boston Globe

After eight complaints including two serious injuries and one patient death, Boston Scientific last night issued a recall for a device designed to filter clots out of the bloodstream.

The Natick firm is recalling 18,000 Greenfield vena cava filters made before March 10, 2004.

The filter is a cone-shaped steel device installed in one of the body's largest veins to catch dangerous clots before they can reach the lungs. It was made with a defect that occasionally allowed the device to detach before it had been implanted, tumbling through the bloodstream and blocking blood flow itself.

People with a filter already implanted in their bodies are not at risk because the problem was in the delivery system and not the filter itself, said company spokesman Charles Rudnick.

The company had detected a problem with the device and changed its manufacturing process in March 2004, but did not issue a recall at the time. Eight months later, a patient died when the product became detached.

The firm waited another year to recall the product because not enough information was available about the incident, said Rudnick.

''It wasn't simply that the patient died," he said. ''We only recently obtained the information we needed to assess what happened."

The Greenfield filter, which has been on the market since 1972, is one of the company's oldest products. According to Boston Scientific's website, more than 600,000 people have had a Greenfield filter implanted.

The recall affects only filters made before March 10, 2004. The firm expects only a ''small fraction" to be returned, said Rudnick.

The updated version of the filter remains on the market.

The product is a relatively small money-earner for the company, bringing in about $20 million a year, compared to around $3 billion for the company's top product, the Taxus coronary stent.

Boston Scientific issued the recall after working with the Food and Drug Administration, according to a press release, and is warning officials in other countries where the product is sold.

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