FDA Device recall Z-1904-2024
Trevo Pro 14 Microcatheter, Catalog: 90231
- FDA Device
- Class II
- ongoing
- Published 2024-06-05
On 2024-06-05 the FDA classified a Class II recall of Trevo Pro 14 Microcatheter, Catalog: 90231 by Stryker Neurovascular, citing neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1904-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-04-23 |
| Published | 2024-06-05 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Stryker Neurovascular |
| Distribution | US |
Product
Trevo Pro 14 Microcatheter, Catalog: 90231; Trevo Pro 18 Microcatheter, Catalog: 90238
Reason
Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.
Identifiers
| code_info | Catalog/UDI-DI/Lot: 90231/00815742002317/121050, 129849, 129882, 130285, 136439, 136628, 143375, 143476; 90238/00815742002386/136009, 198334 |
|---|
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-1904-2024%22
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