Route 92 Medical Recalls Catheters After Distal Tip Separation

Today, a recall of specific Route 92 Medical catheters was categorized by FDA as Class I. The catheters included in the recall include the following:

The company’s catheters are used to deliver microcatheters to the blood vessels in the brain or used as an aspiration catheter to remove blood clots in patients with ischemic stroke. Route 92 is recalling specific lots of its products containing the Tenzing 7 Delivery Catheters after multiple instances of distal tip separation at the proximal marker band.

Of note, the affected products were manufactured by an outside contract supplier of Route 92, not the company itself. After additional investigation, it was also determined that some of these catheters manufactured by the supplier did not meet the company’s quality standards, “particularly in the area of the proximal marker band, so a voluntary recall was initiated,” according to the FDA notice.

Using affected products containing a broken catheter tip may cause delays in surgery, and harm to the blood vessels. If the broken catheter tip is left in the body, it can lead to embolization of catheter fragments. Currently, there has been two injuries and one death reported to be associated with the issue.

On March 8, Route 92 sent all affected customers an urgent field safety notice requesting that all inventory be examined to identify any affected product. If affected product is found, it must then be returned to a site in San Mateo, CA.

Recalled model numbers include:

The recalled catheters were distributed from April 10, 2023, to Feb. 29, 2024.