ev3 Endovascular Trailblazer Support Catheter Recall: Device May Crack

The FDA announced this week a recent class I recall that was issued by ev3 Endovascular, Inc. for their Trailblazer Support Catheter, as the device could crack and potentially cause patients to suffer a heart attack, unnecessary surgery, damage to blood vessels or other potentially life-threatening injuries.

The catheter recall was originally announced in a letter sent out to the company’s customers in November. However, the FDA posted notice of the recall on Tuesday, indicating that the action has been classified as a class I recall, which is the most serious recall classification.

Although ev3 Endovascular, Inc. indicates that there have been no reports of injuries associated with the recalled Trailblazer Support Catheters, 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 health care 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 company recalled the devices after discovering that they could crack near the radiopaque marker band. The cracked catheter could potentially cause serious patient injuries, including blood vessel damage, lack of oxygen to tissues, unplanned surgery, limb amputation, heart attacks and death.

The FDA reports that all of the affected products, which involved 27 lots of the catheters, have been successfully returned to the firm. Any health care professionals or patients who experienced an adverse reaction or event from the use of this product contact the FDA’s MedWatch progam at www.fda.gov/medwatch.