Z-1085-2024Class II

Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm

Name: Z-1085-2024 Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm
Creator: Stryker, Inc.
Published: 2023-12-06
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2023-12-06 / Open, Classified / root cause: labeling and UDI

FDA source

Stryker, Inc. began a recall of Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm on 2023-12-06. FDA classified it as Class II and gives the reason as "The microcatheter IFU contains an intended use that has not been evaluated by the FDA". 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-1085-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-06
Posted: 2024-02-14
Recalling firm: Stryker Corp.
Product: Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm
Product code: QJP Catheter, Percutaneous, Neurovasculature
Reason for recall: The microcatheter IFU contains an intended use that has not been evaluated by the FDA.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: On December 22, 2023, Stryker Neurovascular issued a "Urgent: Medical Device Recall" notification to affected consignees. Stryker asked consignees to take the following actions: Immediately check your internal inventory for affected devices. 2. The affected items may continue to be used. 3. When using impacted lot(s) of Trevo Trak 21 or Trevo Pro 18 microcatheter, please follow the IFU attached in this communication instead of the one that originally came with the device. 4. Circulate this Customer Notification internally to all interested/affected parties. 5. Maintain awareness of this communication internally until all required actions have been completed within your facility. 6. Inform Stryker if any of the subject devices have been distributed to other organizations. If yes, provide contact details so that Stryker can inform the recipients appropriately. 7. Please inform Stryker of any adverse events concerning the use of the subject devices. (US Customer Service: 1-855-91-NEURO (1-855-916-3876), Email: [email protected]) 8. Complete the attached customer response form. It may be that you no longer have any physical inventory on site. Completing this form will allow us to update our records and will also negate the need for us to send any further unnecessary communications on this matter. 9. Email the completed form to [email protected]
Quantity in commerce: 63 units
Distribution: US Nationwide distribution in the states of AL, FL, GA, HI, IL, MI, NC, NH, OH, PA, TX, VA.
Product codes and lots: UDI: (01)07613327313956/Lot Number(s): 0000136913 0000144331, 0000163582, 0000164440, 0000182275, 0000230955, 0000240597, 0000244845, 0000370674

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1085-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1084-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-21	2024-02-14
Z-1085-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-21	2024-02-14

Product code QJP

K211594Class IITrevo Trak 21 MicrocatheterStryker Neurovascular / cleared 2021-11-26

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)