FDA Device recall Z-1386-2022
Trevo Trak 21 Microcatheter, REF: 90338
- FDA Device
- Class II
- ongoing
- Published 2022-07-27
On 2022-07-27 the FDA classified a Class II recall of Trevo Trak 21 Microcatheter, REF: 90338 by Stryker Neurovascular, citing microcatheter product label on the carton is missing the microcatheter product drawing/illustration.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1386-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-06-03 |
| Published | 2022-07-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Stryker Neurovascular |
| Distribution | US |
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
Microcatheter product label on the carton is missing the microcatheter product drawing/illustration.
Identifiers
| code_info | REF/UDI/Lot: 90338/(01)07613327313956(17)231022(10)0000086176/0000086176; OUS: REF/Lot: 91412/46383767; 91413/46402565…REF/UDI/Lot: 90338/(01)07613327313956(17)231022(10)0000086176/0000086176; OUS: REF/Lot: 91412/46383767; 91413/46402565, 46383768, 46383779, 46383776; 91414/46383765, 46383772, 46383773, 46386864, 46383775, 46383774; 91415/46402572, 46383781, 46383771, 46383766; SFP914170/46383769; SFP914190/46383770 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1386-2022%22
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