Connect with us

Company News

Route 92 Medical recalls Catheter due to distal tip separation

Route 92 Medical Inc. is recalling specific lots of Route 92 Medical products containing the Tenzing 7 Delivery Catheters due to multiple instances of distal tip separation at the proximal marker band. The catheters that deconstructed were not manufactured by Route 92 Medical but by an outside contract 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.

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.

There have been two reported injuries and one report of death associated with this issue.

Who may be affected

  • Health care providers that use Route 92 Medical catheters to treat patients with ischemic stroke or other neurovascular diseases or conditions.
  • People who suffer from ischemic stroke or other neurovascular diseases or conditions that are exposed to the Route 92 Medical catheters.

U.S. Food and Drug Administration

Copyright © 2024 Medical Buyer

error: Content is protected !!