PLYMOUTH, Minnesota — Endovascular device company ev3 Inc. in November issued a recall of catheters that could crack and result in serious injury to patients, according to the U.S. Food and Drug Administration.
The company on Nov. 6 sent a letter to its customers outlining the problem and instructing them to locate and remove the affected product, the Trailblazer Support Catheter, according to the FDA.
All of the affected catheters, which were distributed in September and October, have been returned to the firm, the FDA said. A catheter is a thin, flexible tube that is inserted into a vein or body cavity to permit drainage, the injection of fluid or allow access to a surgical instrument.
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It’s unclear whether any patients were harmed by the recalled catheters. An ev3 spokeswoman didn’t immediately return a call.
The FDA said the device could crack and “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.”
An analyst from Piper Jaffray & Co. told the Minneapolis Star-Tribune that it’s his “understanding” that the problem has been fixed and the company is shipping new catheters. Recalls “are a part of standard operations at medical device companies,” he said.
Founded in 2000, ev3 sells a range of products including balloons, stents and coils.
