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FDA Warns of Hydrophilic, Hydrophobic Coatings Risk

Hydrophilic and hydrophobic lubricious coatings can separate from medical devices and harm patients, the U.S. Food and Drug Administration (FDA) warns in a new safety communication that provides steps hospitals and other providers can take to minimize patient risk.

Hydrophilic and hydrophobic lubricious coatings often are found on intravascular and balloon angioplasty catheters, guide wires, delivery sheaths, and implant delivery systems. The coating allows for reduced friction with blood vessels. The FDA, which has determined that the benefits of coated devices outweigh risks, recommends providers take these and other steps to protect patients:

  • Ensure devices are used only as intended by the manufacturer.
  • Follow instructions for proper device storage.
  • Ensure sufficient room for two devices when using both together.
  • Follow preconditioning steps from the manufacturer.
  • Consider replacing a device if it does not move freely, is visibly kinked, or does not perform as expected.

Also, reporting to MedWatch adverse patient safety events related to the separation of hydrophilic or hydrophobic coatings will help FDA further identify and understand the risks associated with medical devices that use these coatings.

Contact Director of Policy Erin O’Malley at or 202.585.0127 with questions.


About the Author

Matt Buechner is the policy and advocacy associate for America's Essential Hospitals.

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