Intravascular Medical Devices: FDA Safety Communication – Lubricious Coating Separation

The FDA wants to make health care providers aware of the possibility that hydrophilic and/or hydrophobic coatings may separate (e.g., peel, flake, shed, delaminate, slough off) from medical devices and potentially cause serious injuries to patients. Coating separation can be caused by a number of factors, ranging from the difficulty of the procedure and the patient’s anatomy to practitioner technique or using the wrong device for the procedure, to improper preconditioning of the device and improper storage conditions as well as issues with device design or manufacturing processes. Based on current information, the FDA believes the overall benefits of these devices continue to outweigh the risks. However, health care providers should be aware of potential problems and consider certain actions prior to use. [11/24/15]

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