FDA Issues Alert on Lubricious Coating Separation

The U.S. Food and Drug Administration (FDA) issued an alert on Nov. 23 about lubricious coating separation on devices such as intravascular catheters, guidewires, balloon angioplasty catheters, delivery sheaths and implant delivery systems. According to the Agency, hydrophilic and/or hydrophobic coatings may peel away from these devices and potentially cause injury to patients.

The FDA encourages health care providers to be aware of these potential problems, but the Agency still “believes the overall benefits of these devices continue to outweigh the risks.”

Read the FDA announcement.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention

Keywords: Angioplasty, Catheterization, Catheters, United States Food and Drug Administration

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