# FDA recall Z-1902-2024

> **Stryker Neurovascular** · Class II · device recall initiated 2024-04-23.

## 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.

## Distribution

Worldwide - US Nationwide distribution including in the states of MN, PA, IL, AK, NY, CA, MI, WI, TX, AZ, FL, KY, MA, IN, NE, MT, CT, NJ, TN, VA, AL, CO, DE, OH, UT, NC, ME, GA, SC, GU, WA, MO, OR, DC, OK, LA, MD, ID, NH, SD, NV, RI, ND, HI, MS, AR, IA, NM, VT, KS and the countries of Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, SAR China, Hungary, India, Ireland, Israel, Italy, Japan, Korea (South), Lithuania, Luxembourg, Netherlands, Northern Ireland, Norway, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Republic of China, Thailand, Turkey, United Arab Emirates, United Kingdom.

## Key facts

- **Recall number:** Z-1902-2024
- **Recalling firm:** Stryker Neurovascular
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-04-23
- **Report date:** 2024-06-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Fremont, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1902-2024

## Citation

> AI Analytics. FDA recall Z-1902-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1902-2024. Source: US FDA. Licensed CC0.

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