Trevo Trak 21 Microcatheter — Class II medical device recall Z-1386-2022
Ongoing recall by Stryker Neurovascular, reported 2022-07-27, distributed nationwide. Microcatheter product label on the carton is missing the microcatheter product drawing/illustration.
| Recall number | Z-1386-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Neurovascular, Fremont, CA, United States |
| Recall initiated | 2022-06-03 |
| Classified | 2022-07-15 |
| Reported by FDA | 2022-07-27 |
| Distributed | Nationwide (US) |
| Quantity | 71 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 07613327313956 |
| Lot numbers | 46383766, 46383768, 46383771, 46383772, 46383773, 46383774, 46383775, 46383776, 46383779, 46383781, 46386864, 90338, 91412/46383767, 91413/46402565, 91414/46383765, 91415/46402572, SFP914170/46383769, SFP914190/46383770 |
| Model numbers | 3-PACKCE, 90338, 91412, 91413, 91414, 91415, SFP914170, SFP914190 |
Product
Trevo Trak 21 Microcatheter, REF: 90338. TREVO NXT 3X32+TRAK21 2-PACK - CE, REF: 91412; TREVO NXT 4X28+TRAK21 2-PACK - CE, REF: 91413; TREVO NXT 4X41+TRAK21 2-PACK - CE, REF: 91414; TREVO NXT 6X37+TRAK21 2-PACK - CE, REF: 91415; TREVO NXT 4X28+TRAK21+CAT6 3-PACK - CE, REF: SFP914170 TREVO NXT 6X37+TRAK21+CAT6 3-PACK - CE, REF: SFP914190. Used in the placement of devices and/or fluids, such as contrast media, into the peripheral, coronary, and neuro vasculature during diagnostic and/or therapeutic procedures.
Reason for recall
Microcatheter product label on the carton is missing the microcatheter product drawing/illustration.
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-1386-2022. 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.