The recall affects about 30 devices that were shipped to distributors outside the U.S., according to a press release. TriVascular said it’s already stopped sales & distribution of the devices "within its control."
"Patient safety and ensuring high quality products are paramount. We are responding quickly and decisively to ensure the continuing safety and efficacy of our products," chairman, president & CEO Christopher Chavez said in prepared remarks. "Above all else, TriVascular is committed to quality."
The Santa Rosa, Calif.-based company said the recall affects the 29mm size, 1 of 5 sizes for the Ovation Prime graft, which is used to treat abdominal aortic aneurysms.
"In letters it will send to international distributors, the company reports an increase in complaints related to incomplete polymer fill of the 29mm stent graft aortic body during the implant procedure. Such failure could lead to transient hypotension, prolonged procedure time, and/or failure to exclude the aneurysm," according to the release. "Although the overall complaint rate is very low (approximately 0.3%) for this issue, the company is responding to a recent trend of complaints specific to the 29mm graft size manufactured within a defined time period."
TriVascular said there’s no risk to patients already implanted with the Ovation Prime device and noted that it’s already improved its manufacturing process to address the problem.
TRIV shares were down 1.6% to $14.81 apiece as of about 12:45 p.m. Eastern today.