Class 1 Device Recall Route 92 Medical Delivery Catheter

• Date Initiated by Firm: March 08, 2024
• Date Posted: April 24, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1613-2024
• Recall Event ID: 94270
• 510(K)Number: K190431
• Product Classification: Catheter, percutaneous - Product Code DQY
• Product: Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of interventional devices into the neurovasculature.
• Code Information: UDI: 00853799007534/ Lot # 23033001, 23073101, 23070305, 23081707
• Recalling Firm/ Manufacturer: ROUTE 92 MEDICAL INC; 155 Bovet Rd Ste 100; San Mateo CA 94402-3151
• Manufacturer Reason for Recall: Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
• FDA Determined Cause: Process control
• Action: On March 12, 2024 Route 92, issued a Urgent Medical Device recall notification to affected consignees via Mail and EMail. Route 92 asked consignees to take the following actions: Ensure all of your SUMMIT MAX inventory including the affected 070 Reperfusion Systems is in a secure, quarantined location. 2. Complete the Acknowledgement Form in Attachment 2 and return to Route 92 Medical by one of the following methods: Email-FieldActions@route92medical.com/Standard Mail - Attention Line: Tenzing 7 fiedl action, 155 Bovet Road Suite 100, San Mateo, CA 94402 Please return the Acknowledgement Form even if you no longer have the product subject to this recall. 4. Immediately return any affected products with the specific lot numbers listed in Attachment 1 to the address above using the original shipping container or request a new shipping container and pre-printed shipping label by email. 5. Keep this notice until all product subject to this recall has been returned. While processing your returns, please maintain a copy of this notice with the quarantined product subject to this recall and keep a copy for your records. 6. Separately, as part of SUMMIT MAX closure, you will be sending back your remaining SUMMIT MAX inventory if you haven t done so already.
• Quantity in Commerce: 200 units
• Distribution: US: AL AZ CA DE FL GA IA IL IN KY LA MA MD MI MN MO NC ND NJ NY OH OR PA RI SD TN TX UT VA WV OUS: New Zealand
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = DQY