Devices & Diagnostics

ev3 says cracked catheter resulted in ‘some adverse events’ but declines to provide specifics

ev3’s cracked Trailblazer Support Catheter did not cause any patient deaths, but the faulty device did result in “some adverse events” to patients, though the company says it doesn’t have further details.

PLYMOUTH, Minnesota — A day after the FDA published details of a company-initiated recall of cracked catheters, ev3 Inc. responded Wednesday, saying the faulty devices resulted in “some adverse events” to patients.

ev3’s cracked Trailblazer Support Catheter did not cause any patient deaths, according to Julie Tracy, the company’s chief communications officer. The faulty device did, however, result in “some adverse events” to patients, but Tracy said she didn’t have further specifics.

Tracy said she couldn’t comment on whether the recall, or the publication of the recall, had resulted in any adverse financial events for the 1,350-employee endovascular device firm, citing an upcoming fourth-quarter earnings announcement, scheduled for next week.

On Nov. 6, ev3 issued a recall of its Trailblazer Support Catheter, which “may crack” on a band 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,” according to the U.S. Food and Drug Administration. The FDA disclosed that recall notice Tuesday.

Tracy said she didn’t know what caused the cracking problem with the device, which is manufactured by ev3.

ev3 issued a statement Wednesday acknowledging that the recall was completed in December and that all the affected catheters have been returned. The company said it notified “28 affected accounts,” resulting in the recall of approximately 350 catheters.

In December, ev3 launched a redesigned Trailblazer Support Catheter, which it is currently selling. The catheters in the recall were manufactured between Sept. 11 and Sept. 29, and distributed between Sept. 21 and Oct. 27, the FDA said. The Trailblazer was a “brand new product” for the company and the recalled catheters were the first of the devices to hit the market, Tracy said.

News of the recall may have had a slightly adverse effect on ev3’s stock price, which in Wednesday afternoon trading had fallen about 3.6 percent to $13.02 from its opening price the previous day.

While recalls can sound scary, they’re often a fact of life for medical device firms. An analyst from Piper Jaffray & Co. told the Minneapolis Star-Tribune that recalls “are a part of standard operations at medical device companies.”

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. Founded in 2000, ev3 sells a range of products for use inside blood vessels, including balloons, stents and coils.