FDA Strengthens Medtronic Catheter Recall Status

Law360, New York (September 29, 2008, 12:00 AM EDT) -- The U.S. Food and Drug Administration has boosted a safety recall for several sutureless catheter models made by Medtronic Inc. to the most severe classification status following dozens of reports of malfunction and one death attributed to the product.

Medtronic announced that the FDA had updated the recall status of the products to Class I on Friday, three months after the medical device maker initially reported problems with some of its intrathecal catheter models to the FDA.

According to a June 2008 letter to the FDA...
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