The U.S. Food and Drug Administration (FDA) has issued a Class I recall, the most serious classification, for certain catheters manufactured by Route 92 Medical Inc. This recall is due to identified risks associated with the devices, which are used in critical neurovascular procedures. These risks include potential for serious injuries or even fatalities. The devices in question are integral to medical practices involving the delivery of microcatheters into the brain’s vasculature and the removal of blood clots from stroke patients, both of which are delicate procedures that demand the highest standards of equipment reliability and safety.
The recall specifically targets multiple models within the Route 92 Medical product line. The affected devices include the 070 Access System, the Tenzing 7 Delivery Catheter, and the Full Length 070 Reperfusion System, among others. These catheters are primarily utilized in the treatment of ischemic stroke and various other neurovascular conditions. The identified defect, a separation of the catheter’s distal tip at the proximal marker band, could lead to severe complications during neurovascular interventions. This defect has been linked to substandard manufacturing processes at one of Route 92 Medical’s external suppliers.
This manufacturing flaw can have dire consequences in a clinical setting. The separation of the catheter tip could lead to unanticipated surgical delays, potential damage to blood vessels, and the risk of leaving fragments of the catheter within the patient’s body. Such scenarios can precipitate further medical complications, including embolization—where a catheter fragment blocks a blood vessel—potentially leading to additional strokes or other serious health issues.
The recall underscores the importance of stringent quality control measures in the manufacturing of medical devices, especially those used in high-risk procedures. It also highlights the critical nature of prompt and decisive action by medical device companies and regulatory bodies when potential risks are identified, ensuring the safety and well-being of patients. Route 92 Medical Inc. and the FDA are working diligently to address these issues, ensuring that all healthcare providers with these devices in their inventory are fully informed of the recall and the necessary steps to mitigate risks to patients.
Details and Scope of the Recall
The devices in question span several product codes—QJP, DQY, and NRY—and include different models marketed under names like Tenzing 7 and part of various systems like the 070 Reperfusion System. These were distributed in the United States from April 10, 2023, to February 29, 2024, with a total of 986 units currently recalled. Route 92 Medical initiated the recall on March 8, 2024, after identifying that certain catheters did not meet their rigorous quality standards, particularly at the proximal marker band constructed by the third-party supplier.
The consequences of using these defective catheters can be severe, including surgery delays, vessel damage, retained catheter tips in the body, and potential embolization (blocking of a blood vessel by a catheter fragment). To date, there have been reports of two injuries and one fatality associated with this defect, emphasizing the critical nature of this recall.
Action Required by Healthcare Providers
Route 92 Medical Inc. has issued an urgent field safety notice to all healthcare providers using these devices. The notice outlines necessary steps to mitigate risk, including:
- Thoroughly checking existing inventory for affected lots.
- Informing relevant personnel and departments about the recall specifics.
- Completing and returning an acknowledgment form provided in the recall notice.
- Arranging for the return of all affected products to Route 92 Medical for safe disposal or replacement.
Healthcare providers must cease using the affected catheters immediately and switch to alternative solutions to ensure patient safety. The notice also emphasizes the importance of monitoring patients who have been treated with these devices for any signs of complications.
Resource: U.S. Food and Drug Administration, May 10, 2024
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