The recall last March of Johnson & Johnson (NYSE:JNJ) unit Cordis Corp.’s Optease vena cava filter is Class I, according to the FDA, meaning the device could cause serious injury or death.
Cordis notified healthcare providers March 29 about 33,000 Optease devices, on concerns that they could be implanted backwards, according to the FDA.
The Miami Lakes, Fla.-based subsidiary notified physicians of corrected labeling "to provide clarification and additional information to minimize likelihood of implanting the filter backwards," according to an FDA notice.
"The company is also making corrections and improvements to the device labeling," the federal watchdog agency said today.
The affected devices were distributed in the U.S. between May 6, 2010 and April 2 of this year, according to the FDA.