The FDA issued a safety alert on Nov. 23 warning of potential issues with coatings peeling or flaking off of intravascular catheters, guidewires, balloon angioplasty catheters, delivery sheaths, implant delivery systems and other medical devices.
Since Jan. 1, 2010, manufacturers have had 11 recalls related to hydrophilic and/or hydrophobic coatings separating from medical devices, according to the FDA. It said most of the recalls were associated with guidewires, but there have also been recalls for sheaths, retrieval devices and embolization device delivery wires used in the vasculature.
Since Jan. 1, 2014, the FDA said it has received approximately 500 reports pertaining to the separation of coatings on medical devices. More than 75 percent of the reports were described as device malfunctions, and the majority were for vascular guidewires. There were also reports for catheters and introducers used for cerebrovascular, cardiovascular and peripheral vascular procedures.
The FDA noted that serious adverse events in the reports and in the scientific literature included pulmonary embolism, pulmonary infarction, myocardial embolism, MI, embolic stroke, tissue necrosis and death. In the reports, some patients had coating fragments in them, which led to surgeries. Other patients had adverse tissue reactions and thrombosis.
“The FDA has not concluded that any specific manufacturer or brand of these devices is associated with higher risks than others,” the agency said in a news release. “The causes of these issues are multifactorial, and can be associated with factors including device design, device manufacturing, and use.”