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FDA Warns Intravascular Devices Can Peel

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By Robert Geimer

The FDA has issued a warning that the coatings on intravascular devices may peel off and cause serious injuries to patients.  In a Safety Communication, the FDA has warned that it has received about 500 reports since early 2014 of these coatings flaking or peeling off intravascular devices such as guidewires, catheters and introducers, which have been used in many different types of medical procedures.  Adverse events include stroke, embolism and heart attack.  Though the FDA has taken the position that the overall benefits of these devices continue to outweigh the risks, it is urging caution in their use and urging physicians to follow a set of recommendation to reduce the risk of flaking and peeling.

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