CLASS II ONGOING Device recall · Reported 16 Oct 2024 · FDA Enforcement Report
The Trevo Trak 21 Microcatheter is a single-lumen recalled
Stryker Neurovascular is recalling The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness, distributed nationwide in the US. The recall was initiated on 30 Aug 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0021-2025
- FDA event ID
- 95314
- Recalling firm
- Stryker Neurovascular, Fremont, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Aug 2024
- FDA classified
- 7 Oct 2024
- Reported
- 16 Oct 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 30 Aug 2024 | Recall initiated by company | |
| 7 Oct 2024 | Classified by FDA | +38 days |
| 16 Oct 2024 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Stryker Neurovascular has observed that devices with Out of United States (OUS) approved Instructions for Use (IFU) and Packaging Labels (pouch and carton), different configurations, have been erroneously distributed to customers in the US.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating on the distal 100cm to reduce friction during use. The radiopaque shaft and distal marker(s) facilitate fluoroscopic visualization. A rotating hemostatic valve with side-arm adapter is provided with each microcatheter.
Where it was distributed
U.S. Nationwide distribution in the states of CA and VA.
Questions about this recall
Why was it recalled?
Stryker Neurovascular has observed that devices with Out of United States (OUS) approved Instructions for Use (IFU) and Packaging Labels (pouch and carton), different configurations, have been erroneously distributed to customers in the US.
Which lots are affected?
Model/Catalog Number: 90338 UDI Codes: (01)07613327313956(17)251125(10)0000590444 (01)07613327313956(17)260101(10)0000603275 Lot Numbers: 0000590444 0000603275
Where was it sold?
U.S. Nationwide distribution in the states of CA and VA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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