EV3 Inc. EverFlex Self-Expanding Biliary Stent Systems Recalled by the FDA
Posted Jan 05 2010 6:31pm
The notice from the FDA can be read here. This is the page on the EverFlex products and I didn’t see a notice as to which one was involved in the recall from the FDA. Model # PRB35-06-150-080 and Model Number PRP35-06-100-080 are listed on the FDA page as the recalled items. If you look at the page there’s quite an extensive list of stents the company manufactures and it is only the two models listed above on the list.
The warning from the FDA says the stents could crack and lead injury, heart attack, limb amputation and death. BD
WASHINGTON, Jan 5 (Reuters) - Endovascular device maker ev3 Inc (EVVV.O) has recalled certain trailblazer support catheters that may crack and cause serious injuries or death, U.S. health officials said on Tuesday.
The company notified doctors about the recall when it was initiated in November 2009, according to a notice on the Food and Drug Administration's website.
The FDA said the catheters may crack "near the radiopaque marker band."
"This may result in serious patient injury, including insufficient oxygen supply to the tissues, damage to blood vessels, heart attack, limb amputation, unplanned surgery, and/or death," the agency said. The recalled catheters were manufactured from Sept. 11, 2009, through Sept. 29, 2009, and distributed from Sept. 21, 2009, through Oct. 27, 2009.