FDA Device recall Z-1614-2024
Route 92 Medical 070 Reperfusion System, REF 1003, Rxonly, SterileEO. Used for introduction of interventional devices into the neurovascula…
- FDA Device
- Class I
- ongoing
- Published 2024-05-01
On 2024-05-01 the FDA classified a Class I recall of Route 92 Medical 070 Reperfusion System, REF 1003, Rxonly, SterileEO. Used for introduction of interventional devices into the neurovascula… by Route 92 Medical, citing their is the potential for distal tip separation at the proximal marker band of the delivery catheters.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1614-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-03-08 |
| Published | 2024-05-01 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Route 92 Medical |
| Distribution | 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 |
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
Identifiers
| code_info | UDI: 00853799007169/ Lot # 23112702 and 23112901 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1614-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.