The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Product

• Product Names:
  • 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
• Product Codes: QJP, DQY, NRY
• Model Numbers:
  • K190431 Route 92 Medical Delivery Catheter (DQY), as 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
• Distribution Dates: April 10, 2023, to February 29, 2024
• Devices Recalled in the U.S.: 986
• Date Initiated by Firm: March 8, 2024

Device Use

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Translation

The Route 92 Medical catheters are used to deliver microcatheters to the blood vessels in the brain (neurovasculature) or used as an aspiration catheter to remove blood clots in patients with ischemic stroke.

Reason for Recall

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 no 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.

What to Do

On March 8, 2024, Route 92 Medical Inc. sent all affected customers an urgent field safety notice.

The letter requested customers to:

• Examine inventory and identify any affected lots.
• Communicate the issue to anyone who needs to be informed.
• Complete the included acknowledgement form and return to Route 92 Medical either by email or using the standard mailing address below.

Attention Line: Tenzing 7 Field Action
155 Bovet Road, Suite 100
San Mateo, CA 94402

• Arrange returns for any affected product remaining on site or that may have been forwarded to other facilities. All affected products should be returned to the address above.

Contact Information

Customers in the U.S. with questions about this recall should contact Route 92 Medical at fieldactions@route92medical.com.

Additional Resources:

• 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

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.