Route 92 Medical is recalling specific lots of its products containing the Tenzing 7 delivery catheters due to multiple instances of distal-tip separation at the proximal marker band. This recall has been identified by the US Food and Drug Administration (FDA) as a Class I recall—the most serious type of recall, meaning that use of these devices may cause serious injuries or death.
A recall notice released by the FDA on 10 May 2024 states that the catheters in question that ‘deconstructed’ were not manufactured by Route 92 but by an outside contract supplier. Additional investigations determined that some of these catheters manufactured by said outside supplier did not meet Route 92’s quality standards—particularly in the area of the proximal marker band—leading the company to initiate a voluntary recall on 8 March.
An FDA statement notes that a broken catheter tip such as this may result in delays in surgery, harm to blood vessels, the broken catheter tip being left in the body, and the blocking or stopping of blood flow in a vessel due to catheter fragments. There have been one report of death and no reported injuries associated with this issue, according to the FDA.
Route 92’s catheters are used to deliver microcatheters to the neurovasculature, or as aspiration catheters during mechanical thrombectomy procedures to remove blood clots in patients with ischaemic stroke.
The FDA’s statement notes that, on 8 March, the company sent all affected customers an urgent field safety notice requesting customers to examine inventory and identify any affected lots; communicate the issue to anyone who needs to be informed; complete an included acknowledgement form to be returned to Route 92 either by email or post; and arrange returns for any affected product remaining on site or that may have been forwarded to other facilities.
According to the FDA, the specific products relevant to this device recall are the aforementioned Tenzing 7 delivery catheter itself, as well as the Route 92 Medical 070 access and 070 reperfusion systems—including the full-length 070 versions of both. The Route 92 Medical 088 and 070 reperfusion systems, and the Route 92 Medical aspiration tubing set being used in the SUMMIT MAX trial, are also covered by the recall.
A total of 986 catheters have been recalled by Route 92 in the USA as a result of these concerns over distal-tip separation.
Healthcare professionals and consumers can report adverse reactions or quality problems they have experienced while using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
