Recall Z-1614-2024— ROUTE 92 MEDICAL INC
Class I · Ongoing
Class I FDA medical device recall by ROUTE 92 MEDICAL INC, initiated 2024-03-08. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: Their is the potential for distal tip separation at the proximal marker band of the delivery catheters.
- Recalling firm
- ROUTE 92 MEDICAL INC
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2024-03-08
- Firm location
- San Mateo, CA, United States
Product description
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.
Reason for recall
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Data sourced from openFDA. This site is unofficial and independent of the FDA.