FDA announces new recall of delivery catheters after patient’s death
The U.S. Food and Drug Administration (FDA) has announced that California-based Route 92 Medical is recalling nearly 1,000 medical devices used to treat stroke patients due to significant safety concerns. The FDA categorized this as a Class I recall, which means using the devices “may cause serious injuries or death.”
The recall includes specific lots of the following products:
- Route 92 Medical 070 Access System
- Tenzing 7 Delivery Catheter
- Route 92 Medical 070 Reperfusion System
- Route 92 Medical Full Length 070 Reperfusion System
- Route 92 Medical Full Length 070 Access System
These devices are all used to either deliver microcatheters to blood vessels in the brain, or assist with blood clot removal in patients with ischemic stroke. Each one includes a Tenzing 7 Delivery Catheter, a single-lumen device with two radiopaque markers, and one of them is simply the Tenzing 7 Delivery Catheter sold on its own. The recall was been put in place because the distal tip of these delivery catheters can separate at the proximal marker band.
According to Route 92 Medical, the delivery catheters were all manufactured by an outside supplier.
“Additional investigations determined that some of these catheters manufactured by this outside supplier did not meet Route 92 Medical’s quality standards, particularly in the area of the proximal marker band, so a voluntary recall was initiated,” according to the advisory. “The broken catheter tip can cause delays in surgery, harm to blood vessels, having the broken catheter tip left in the body, and lead to the blocking or stopping of blood flow in a blood vessel (embolization) of catheter fragments.”
Two injuries and one death have been associated with the ongoing issue.
Route 92 Medical sent its customers an urgent notice about the recall on March 8. Customers were told to examine their inventory, identify any devices that are included in the recall and then return the affected products right away.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.