Trevo XP ProVue Retriever — Class I medical device recall Z-0114-2021
Terminated recall by Stryker Neurovascular, reported 2020-10-28, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Increase in fracture complaints of the flexible, tapered core wire, resulting in stent retriever separation fr
| Recall number | Z-0114-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Neurovascular, Fremont, CA, United States |
| Recall initiated | 2020-09-21 |
| Classified | 2020-10-20 |
| Reported by FDA | 2020-10-28 |
| Terminated | 2024-04-01 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV |
| Countries outside the US | AE, AR, AT, AU, BE, BR, CA, CH, CL, CO, CZ, DE, DK, EE, EG, ES, FI, FR, GB, GR, HK, HR, HU, IE, IL, IN, IT, JP, KR, LT, LU, MX, NL, NO, NZ, PH, PL, PT, RO, SA, SE, SG, SI, SK, TH, TR, TW, VN, ZA |
| Quantity | 5,365 |
| Reason classes | device malfunction |
| Lot numbers | 0000030024, 0000030025, 0000030026, 0000030030, 0000030031, 0000030032, 0000030251, 0000030252, 0000030253, 0000030260, 0000030261, 0000030262, 0000030406, 0000030407, 0000030408, 0000030409, 0000030410, 0000030415, 0000030416, 0000030417, 0000030418, 0000030419, 0000030921, 0000030922, 0000030924, 0000030925, 0000030926, 0000030927, 0000030928, 0000030929, 0000030930, 0000030931, 0000031336, 0000031338, 0000031339, 0000031340, 0000031341, 0000031585, 0000031587, 0000031588 and 460 more |
| Model numbers | 0000030024, 0000030025, 0000030026, 0000030251, 0000030252, 0000030253, 0000030408, 0000030409, 0000030410, 0000030921, 0000030922, 0000030931, 0000031336, 0000031585, 0000031761, 0000031762, 0000031763, 0000032042, 0000032043, 0000032309, 0000032310, 0000032400, 0000032401, 0000032402, 0000032403 and 22 more |
Product
Trevo XP ProVue Retriever, REF (Size): 90182 (4MM x 20MM); 90185 (4MM x 30MM); 90186 (6MM x 25MM). Procedure Pack REF: 80052, 93067, 93068, M0032PK42010001, M0033PK42022001, M0033PK43022001, M0033PK62523001, M0032PK42010002, M0032PK43010002, M0032PK62510002, M0033PK42022002, M0033PK43022002, M0033PK62523002
Reason for recall
Increase in fracture complaints of the flexible, tapered core wire, resulting in stent retriever separation from the core wire during use. The stent retriever can be left behind in the vasculature.
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-0114-2021. 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.