FDA Enforcement
Class I
Ongoing
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.
Recall: Z-1614-2024
·
Reported May 1, 2024
Enforcement
- Recall Number
- Z-1614-2024
- Event ID
- 94270
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- ROUTE 92 MEDICAL INC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 1, 2024
- Initiation Date
- March 8, 2024
- Classification Date
- April 24, 2024
- Address
- 155 Bovet Rd Ste 100, N/A, San Mateo, CA, 94402-3151, United States
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
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Code Info
UDI: 00853799007169/ Lot # 23112702 and 23112901
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
Quantity
19 units