Institute of Good Manufacturing Practices India®

(An Autonomous Body Recognized by Ministry of Commerce & Industry, Government of India)

Route 92 catheter recall associated with 2 injuries, 1 death

Route 92 Medical has recalled about 1,000 catheters in the U.S. due to malfunctions linked to two patient injuries and one death, as per the FDA. Physicians use these catheters to deliver microcatheters to brain blood vessels or remove clots in stroke patients. Route 92 received reports of broken catheter tips halting blood flow, stemming from devices made by an external contractor that failed to meet Route 92's quality standards.

Their Tenzing 7 catheter, designed to navigate brain blood clots without crossing the blockage site, addresses challenges posed by larger diameter aspiration catheters, competing with companies like Stryker in the stroke market.

The recall, initiated in March, involves devices distributed from April 2023 to February 2024, impacting the delivery catheter and associated systems. The FDA classified it as a Class I event due to risks like surgery delays and vessel damage. Route 92 urged customers to promptly return affected products.