Dive Brief:
- Route 92 Medical has recalled nearly 1,000 catheters from the U.S. due to malfunctions related to two reports of patient injuries and one death, according to a recall notice posted Friday by the Food and Drug Administration.
- Physicians use the devices to deliver microcatheters to blood vessels in the brain or remove clots in stroke patients. Route 92 received reports of broken catheter tips that could stop blood flow.
- The problem affects devices made by an outside contract supplier. The devices failed to meet Route 92’s quality standards, the FDA said, leading the company to recall the products.
Dive Insight:
California-based Route 92 designed its Tenzing 7 catheter to deliver catheters to blood clots in the brain without crossing the site of the blockage. The design reflects the challenges that have arisen as physicians have started to use larger diameter aspiration catheters. Route 92 competes with medtech companies such as Stryker for the stroke market
Route 92 received 510(k) clearance for the delivery catheter in 2019. The company is running a clinical trial of a system featuring the catheter, and it raised more than $31 million in November to accelerate the commercialization of the Tenzing 7 delivery catheter and associated systems.
In March, Route 92 began recalling devices distributed from April 2023 to February 2024. The recall, which affects the delivery catheter and the associated systems, follows “multiple instances of distal tip separation at the proximal marker band,” the FDA said. Investigations showed the devices fell short of quality standards, particularly in the area of the proximal marker band.
A broken catheter tip can delay surgeries, harm blood vessels, block blood flow and have the broken tip left in the body, the FDA said. Those risks informed the FDA’s decision to categorize the recall as a Class I event.
Route 92 asked customers to arrange the return of affected products.
