FDA alerts to Class I recall of specific Route 92 Medical catheter products due to risk of major injuries, death

According to the FDA, Route 92 Medical Inc. has recalled three lots of its Tenzing 7 Delivery Catheter products after receiving multiple reports of “distal tip separation at the proximal marker band.”

Initiated by the firm on March 8, 2024, an FDA update posted May 10, 2024, has labeled the recall as Class I, the most serious type, because the defect poses a risk of serious injury and death.

The recall covers 986 devices that were distributed in the U.S. between April 10, 2023, and February 29, 2024. Affected products can be found under the following product names, codes. Model numbers can be referenced in the FDA communication.

Product Names:

  • Route 92 Medical 070 Access System
  • Tenzing 7 Delivery Catheter
  • Route 92 Medical 070 Reperfusion System
  • Route 92 Medical Full Length 070 Referfusion System
  • Route 92 Medical Full Length 070 Access System

Product Codes: QJP, DQY, NRY

Designed to deliver microcatheters to the brain’s blood vessels, Route 92 Medical catheters are also used as aspiration catheters, which removes blood clots in ischemic stroke patients.

Company officials say the catheter tip was found to be broken, or separated, in specific lots of products featuring Tenzing 7 Delivery Catheters, which may result in a range of problems: surgery delays, injury to blood vessels, the tip of the broken catheter being left in the body, and the blockage of blood flow in a blood vessel because of the catheter fragments.

To date of the May 10, 2024 FDA update, Route 92 Medical has received no reports of injuries and “one report of death” in connection to the issue.

Those who may be affected by the recall include ischemic stroke patients, or people who suffer from other neurovascular diseases and conditions who are exposed to the affected devices. Healthcare providers who treat such patients using the catheters are also advised of the risk.

A field safety notice was promptly sent out to all Route 92 Medical Inc. customers on March 8, 2024, making the following requests:

  • Identify any affected lots kept in inventory
  • Inform all relevant personnel or other parties about the issue
  • Acknowledge receipt of the information in the safety notice by completing the attached form and returning it to Route 92 Medical via email or standard mail, using the address provided.
  • Ensure that any affected product on site or at other associated facilities be arranged for return to the Tenzing 7 Field Action address in San Mateo, CA.

Additional questions about the recall may be directed to Route 92 Medical via email at fieldactions@route92medical.com.

As the FDA continues to monitor this recall, healthcare professionals and consumers are urged to report any related adverse events or experiences to the agency’s MedWatch program.


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