FDA Device Recall Z-1614-2024
ROUTE 92 MEDICAL INC · San Mateo, CA
Class I — life-threatening Ongoing
Device
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
Recall record
- Recall number
Z-1614-2024- Classification
- Class I
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- 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
- Recall initiated
- 2024-03-08
- Classified by FDA Center
- 2024-04-24
- FDA published
- 2024-05-01
- Recalling firm
- ROUTE 92 MEDICAL INC
- Firm location
- San Mateo, CA
Operational response
A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.
For the official FDA enforcement record, see FDA's Recall Search.