FDA Bars Medtronic Catheter Imports Amid 'Serious' Miscues

Law360, New York (June 25, 2013, 5:11 PM EDT) -- The U.S. Food and Drug Administration on Tuesday disclosed that it has blocked imports of two Medtronic Inc. catheter products after finding that the company failed to prevent microbial contamination, properly certify software and promptly notify regulators of recalls.

The action, detailed in a warning letter dated May 6, came in response to inspections at an Italian location of Medtronic subsidiary Invatec SpA that allegedly turned up a host of problems with the manufacturing of products used to treat diseased arteries.

Citing the “serious nature of...
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