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.