Z-1386-2022Class II

Trevo Trak 21 Microcatheter, REF: 90338. TREVO NXT 3X32+TRAK21 2-PACK - CE, REF: 91412; TREVO NXT 4X28+TRAK21...

Name: Z-1386-2022 Trevo Trak 21 Microcatheter, REF: 90338. TREVO NXT 3X32+TRAK21 2-PACK - CE, REF: 91412; TREVO NXT 4X28+TRAK21...
Creator: Stryker Neurovascular
Published: 2022-06-03
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2022-06-03 / Open, Classified / root cause: labeling and UDI

FDA source

Stryker Neurovascular began a recall of 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... on 2022-06-03. FDA classified it as Class II and gives the reason as "Microcatheter product label on the carton is missing the microcatheter product drawing/illustration". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1386-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-06-03
Posted: 2022-07-15
Recalling firm: Stryker Corp.
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.
Product code: DQO Catheter, Intravascular, Diagnostic
Reason for recall: Microcatheter product label on the carton is missing the microcatheter product drawing/illustration.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: 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 [email protected]
Quantity in commerce: 71
Distribution: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1386-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1386-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-27	2022-07-15

Product code DQO

K192122Class IITrevo Trak 21 MicrocatheterStryker / cleared 2019-11-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)