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Product liability: FDA warns about dangerous medical devices

Medical devices with hydrophobic and/or hydrophilic coatings have been in use for over 20 years. The function of the coatings is to lessen the friction between devices and blood vessels. The Food and Drug Administration recently brought awareness to the dangers posed by these coatings. Reportedly, they have been linked to 11 deaths of patients nationwide. In California and elsewhere, these types of issues often lead to product liability litigation. 

The FDA said the coatings could detach from the devices and cause severe injuries that may even lead to death. The devices with the friction-reducing coatings include guidewires, angioplasty catheters (both balloon and intravascular), implant delivery systems and delivery sheaths. Since Jan. 2010, 11 devices have been recalled. Since Jan. 2014, the FDA also received about 500 Medical Device Reports about the same problem.

Health care providers were advised to follow different steps designed to prevent the peeling off or flaking of the hydrophobic and/or hydrophilic coatings. Factors to consider include proper storage of the devices, the intended use and a good fit when two such devices are used at the same time. Also, physicians must follow the instructions provided by the manufacturers related to the preconditioning process that activates the coating's lubricious properties.

Although this technology has benefited millions of people, it has caused death in a limited number of cases. California families who have lost loved ones due to defective medical devices may pursue litigation to seek financial accountability from the manufacturers of such devices. Proving negligence may not be easy, and the assistance of an experienced product liability attorney is typically essential. With effective legal counsel and a properly presented claim, the surviving family members may be awarded monetary compensation for documented financial and emotional losses.

Source:, "FDA warns about coatings separating from medical devices, sometimes with lethal results", Norbert Sparrow, Nov. 24, 2015

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