Class I — Stryker Neurovascular
| Recalling firm | STRYKER CORP. |
|---|---|
| Registered facility | View this company's 61 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | 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. |
| 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 |
| Quantity | 5365 |
| Distribution | U.S.: PA, OH, AK, NY, VA, IL, CA, NJ, AL, NV, FL, KY, AR, MA, TX, MI, NC, TN, WI, WA, AZ, OR, GA, VT, UT, DC, MO, IN, OK, NH, LA, HI, DE, SC, MS, RI, MD, SD, KS, ID, CO, CT, IA, NM, WV, MN, GU, NE. Foreign: New Zealand, Argentina, Estonia, Lithuania, Slovenia, Australia, Finland, Luxembourg, South Africa, Austria, France, Mexico, South Korea, Belgium, Germany, Netherlands, Spain, Brazil, Greece… |
| Initiated | 2020-09-21 |
| Classified | 2020-10-20 |
| Terminated | 2024-04-01 |
| Recall number | Z-0114-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Stryker Neurovascular (Z-0114-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86583/
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