Medtronic Catheter, Tube Combo Prompts Recall

Law360, New York (September 14, 2009, 3:14 PM EDT) -- Medtronic Inc. has said that a catheter and an infusion pump it produces pose serious health risks when used together, prompting the U.S. Food and Drug Administration to classify the combination as a Class 1 recall.

The FDA's decision would not stop production or marketing of the two products – the Sutureless Connector intrathecal catheter and the IsoMed constant-flow infusion pump – because they only pose risks when used together, Medtronic spokeswoman Cindy Resman said Monday.

Ten people have reported adverse reactions to the catheter-pump combination,...
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