Recall Z-1614-2024 ยท DQY Catheter, Percutaneous
ROUTE 92 MEDICAL INC
Route 92 Medical 070 Reperfusion System, REF 1003, Rxonly, SterileEO. Used for introduction of interventional devices into the neurovasculature and aspiration of thrombus in ischemic stroke patients.
| Date | Apr 24, 2024 (initiated Mar 8, 2024) |
| Status | Open, Classified |
| Reason | Their is the potential for distal tip separation at the proximal marker band of the delivery catheters |
| Root 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 |
| Quantity | 19 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.