Warning: Lubricious Coatings on Intravascular Devices

The FDA has warned that hydrophilic and/or hydrophobic coatings may separate (e.g., peel, flake, shed, delaminate, slough off) from intravascular medical devices and potentially cause serious injuries to patients.  Coating separation can be caused by the difficulty of the procedure, patient’s anatomy, practitioner technique, using the wrong device for the procedure, improper preconditioning of the device, improper storage conditions, or issues with device design or manufacturing processes.  The FDA provides a long list of cautions and recommendations, at http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm473794.htm .

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