Ev3 Endovascular Launches Redesign of Recalled TrailBlazer Support Catheter
Ev3 Endovascular Inc. (Plymouth, MN) launched a redesign of the company's TrailBlazer Support Catheter in December 2009 that is now available globally. The product redesign was the next step taken by the endovascular company in response to a product safety issue that resulted in a voluntary class I recall issued in January for Trailblazer Support Catheters.
The recall applied only to those Trailblazer Support Catheters manufactured from Sept. 11, 2009 through Sept. 29, 2009 and distributed from Sept. 21, 2009 through Oct. 27, 2009. Ev3 Endovascular received reports of cracking on the device near the radiopaque marker band from physicians during the initial limited market release of the device in the United States. The cracked catheter had the potential to cause serious patient injuries, such as blood vessel damage, lack of oxygen to tissues, unplanned surgery, limb amputation, heart attacks, and death.
FDA reports that all of the affected products, which involved 27 lots of the catheters, have been successfully returned to the firm.
The catheter recall was originally announced in a letter sent out to the company’s customers in November, however, FDA posted notice of the recall in January, indicating that the action has been classified as a class I recall, which is the most serious recall classification. Ev3 Endovascular indicates that there have been no reports of injuries associated with the recalled Trailblazer Support Catheters, however, class I recalls are only declared in situations where the use of a product poses a reasonable probability of serious injury or death.
The support catheters are used by healthcare professionals to access veins and blood vessels. Once in place in the skin, they can be used to guide and support a guide wire, allowing an opening that can be used for a variety of medical purposes, such as introducing medication directly into the bloodstream.
The recall included Model Numbers SC-014-135, SC-018-090, SC-035-065, SC-035-135, SC-014-150, SC-018-150, SC-035-090, and SC-035-150.