Devices

Route 92 Medical Recalls Faulty Catheters

Route 92 Medical is recalling (Class 1) several lots of its products containing the Tenzing 7 Delivery Catheters due to multiple instances of distal tip separation at the proximal marker band. The catheters that separated were made by an outside contract manufacturer, a recall notice says. “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,” it says.

The company says a broken catheter tip can cause delays in surgery, harm to blood vessels, and lead to a blood flow blockage in a blood vessel (embolization) from the catheter fragments. To date, the notice says there have been two reported injuries and one death associated with the issue.

The catheters are used to deliver microcatheters to blood vessels in the brain (neurovasculature) or used as an aspiration catheter to remove blood clots in patients with ischemic stroke.

Gupta Raises Concerns About Overton’s Independence, Ideology

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome