—#194534

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.

FDA product code: DQO — Catheter, Intravascular, Diagnostic
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K192122
Affected lot / code info: 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

Why it was recalled

Microcatheter product label on the carton is missing the microcatheter product drawing/illustration.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

On 06/03/22 Field Action notifications were mailed to customers who were informed of the following: 1) The affected items may continue to be used. Refer to the inner pouch label for the product drawing/illustration. 2) Circulate and maintain awareness of this Customer Notification internally to all interested/affected parties. 3) Inform the recalling firm if any of the subject devices have been distributed to other organizations. If yes, provide contact details so that the recalling firm can inform the recipients appropriately. 7. Please inform the recalling firm of any adverse events concerning the use of the subject devices. 8. Complete and return the the customer response form. The response form or questions can be addressed to your local firm representative or via email to nvfieldactions@stryker.com

Recalling firm

Firm: Stryker Neurovascular
Address: 47900 Bayside Pkwy, Fremont, California 94538-6515

Distribution

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.

Timeline

Recall initiated: 2022-06-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #194534. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.