Device 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.
Z-1386-2022
Product summary
- Event
- Event 90482
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 71
- Official record key
device-enforcement:Z-1386-2022
Official wording
Reason: Microcatheter product label on the carton is missing the microcatheter product drawing/illustration.
Code information: 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
Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of CA, OR, PA, NY, DC, IL, WA, NH, NJ, OK, FL, AZ, AL, GA, TX, WI, VA and the countries of DE, IT, AT.
Derived failure modes
-
Labeling or packaging
label on the carton is missing