FDA Device recall Z-1902-2024
Trevo XP ProVue Retriever 4 x 20, Catalog: 90182 Trevo XP ProVue Retriever 3 x 20, Catalog: 90183 Trevo XP ProVue Retriever 4 x 30, Catalog…
- FDA Device
- Class II
- ongoing
- Published 2024-06-05
On 2024-06-05 the FDA classified a Class II recall of Trevo XP ProVue Retriever 4 x 20, Catalog: 90182 Trevo XP ProVue Retriever 3 x 20, Catalog: 90183 Trevo XP ProVue Retriever 4 x 30, Catalog… 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-1902-2024 |
| 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 XP ProVue Retriever 4 x 20, Catalog: 90182 Trevo XP ProVue Retriever 3 x 20, Catalog: 90183 Trevo XP ProVue Retriever 4 x 30, Catalog: 90185 Trevo XP ProVue Retriever 6 x 25, Catalog: 90186 Kits: TREVO XP 3X20+PRO14 2-PACK, Catalog: 80051 TREVO XP 4X20+PRO18 2-PACK, Catalog: 80052 TREVO XP 4X30+PRO18 2-PACK, Catalog: 93067 TREVO XP 6X25+XT27 2-PACK, Catalog: 93068 TREVO XP 3X20+PRO14+CAT6 3-PACK - CE, Catalog: M0033PK32021002 TREVO XP 4X20+PRO18+CAT6 3-PACK - CE, Catalog: M0033PK42022002 TREVO XP 6X25+XT27+CAT6 3-PACK - CE, Catalog: M0033PK62523002
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: 90182/00815742001822/116706; 90183/00815742001839/117514; 90185/00815742001853/118900; 90186/008…Catalog/UDI-DI/Lot: 90182/00815742001822/116706; 90183/00815742001839/117514; 90185/00815742001853/118900; 90186/00815742001860/114054; 80051/00815742000511/47307561, 47328877, 47351811, 47398058, 47398074, 48521577, 48521585, 48540280, 48540281, 48540282, 48540283, 48540284, 48556786, 48588490, 48607589, 48676218, 48696629, 48715720, 48736116, 48736122, 48754915, 48754920, 48772012, 48772014, 48772025, 50065499, 50065511, 50065512, 50065513, 50065514, 50065515, 50065518, 50113384, 50113385, 50133176, 50133191, 50193582, 50216273, 50216274, 50216277, 50239676, 50260575, 50260583, 50280979, 50281011, 50304688, 50304712, 50304713, 50304714, 50397877, 50422572, 50422582, 50422589, 50448279, 50519274, 50519275, 50519276, 50519277, 50519285, 50519295, 50577572, 50607374, 50607376, 50607377, 50607378, 50650278, 50650279, 50650288, 50673881, 50673884, 50673908, 50673909, 50673910, 50673911, 50673930, 50694279, 50738912, 50786710, 50850697, 50869887, 50869892, 50869905, 50886487, 50912493, |
|---|
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-1902-2024%22
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