Trevo XP ProVue Retriever 4 x 20 — Class II medical device recall Z-1902-2024
Ongoing recall by Stryker Neurovascular, reported 2024-06-05, distributed nationwide. Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing
| Recall number | Z-1902-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Neurovascular, Fremont, CA, United States |
| Recall initiated | 2024-04-23 |
| Classified | 2024-05-28 |
| Reported by FDA | 2024-06-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BR, CA, CH, CL, CN, CZ, DE, DK, ES, FI, FR, GB, HK, HU, IE, IL, IN, IT, JP, KR, LT, LU, NL, NO, PL, PT, RO, SA, SE, SG, SK, TH, TR, TW |
| Quantity | 461 |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00815742000511, 00815742000528, 00815742000672, 00815742000689, 00815742001822, 00815742001839, 00815742001853, 00815742001860, 07613327126334, 07613327126358, 07613327126365 |
| Lot numbers | 47328877, 47351811, 47398058, 47398074, 48521577, 48521585, 48540280, 48540281, 48540282, 48540283, 48540284, 48556786, 48588490, 48607589, 48624226, 48641523, 48641533, 48676218, 48696629, 48715720, 48736116, 48736122, 48754915, 48754920, 48772012, 48772014, 48772025, 49021115, 49021116, 49021117, 49021118, 49033114, 49033115, 49033116, 49033117, 49033123, 49052517, 49052525, 49056315, 49140624 and 119 more |
| Model numbers | 3-PACKCE, 80051, 80052, 90182, 90183, 90185, 90186, 93067, 93068, M0033PK32021002, M0033PK42022002, M0033PK62523002 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1902-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.