Route 92 Medical Recalls Catheters After Distal Tip Separation

The affected catheters were manufactured by an outside contract supplier, not by the company itself.

Katie Hobbins, Managing Editor

May 10, 2024

2 Min Read
FDA recall
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Today, a recall of specific Route 92 Medical catheters was categorized by FDA as Class I. The catheters included in the recall include the following:

The company’s catheters are used to deliver microcatheters to the blood vessels in the brain or used as an aspiration catheter to remove blood clots in patients with ischemic stroke. Route 92 is recalling specific lots of its products containing the Tenzing 7 Delivery Catheters after multiple instances of distal tip separation at the proximal marker band.

Of note, the affected products were manufactured by an outside contract supplier of Route 92, not the company itself. After additional investigation, it was also determined that some of these catheters manufactured by the supplier did not meet the company’s quality standards, “particularly in the area of the proximal marker band, so a voluntary recall was initiated,” according to the FDA notice.

Using affected products containing a broken catheter tip may cause delays in surgery, and harm to the blood vessels. If the broken catheter tip is left in the body, it can lead to embolization of catheter fragments. Currently, there has been two injuries and one death reported to be associated with the issue.

On March 8, Route 92 sent all affected customers an urgent field safety notice requesting that all inventory be examined to identify any affected product. If affected product is found, it must then be returned to a site in San Mateo, CA.

Recalled model numbers include:

  • K190431 Route 92 Medical Delivery Catheter (DQY), also known as Tenzing 7 and sold separately.

  • K203043 Route 92 Medical 070 Access System (QJP) recall device sold as part of a system.

  • K222743 Route 92 Medical Full Length 070 Access System (QJP) recall device sold as part of a system.

  • K223530 Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set (NRY) recall device sold as part of a system.

  • G210002 Route 92 Medical 088 Reperfusion System; Route 92 Medical 070 Reperfusion System; Route 92 Medical Aspiration Tubing Set in the SUMMIT MAX trial.

The recalled catheters were distributed from April 10, 2023, to Feb. 29, 2024.

About the Author(s)

Katie Hobbins

Managing Editor, MD+DI

Katie Hobbins is managing editor for MD+DI and joined the team in July 2022. She boasts multiple previous editorial roles in print and multimedia medical journalism, including dermatology, medical aesthetics, and pediatric medicine. She graduated from Cleveland State University in 2018 with a bachelor's degree in journalism and promotional communications. She enjoys yoga, hand embroidery, and anything DIY. You can reach her at [email protected].

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