FDA Device recall Z-1612-2024
Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for introduction of interventional devices into the neurovasculatu…
- 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 Access System, REF 1004, Rxonly , Sterile EO. Used for introduction of interventional devices into the neurovasculatu… 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-1612-2024 |
| 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 Access System, REF 1004, Rxonly , Sterile EO. Used for introduction of interventional devices into the neurovasculature.
Reason
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Identifiers
| code_info | UDI: 00853799007442/ Lot # 23061601 24010306, 23081802, 24011801, 23100601, 24020801, 23102601 |
|---|
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-1612-2024%22
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