Stryker Trevo Trak 21 Microcatheter recalled for missing carton product illustration
Stryker Neurovascular is recalling 71 Trevo Trak 21 Microcatheter units because the product carton label is missing the required product drawing or illustration.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II device with a labeling defect—specifically a missing product drawing or illustration on the carton. No illnesses or injuries have been reported. Per the severity rubric, minor labeling errors are scored as Moderate (2).
Plain-English summary
Stryker Neurovascular is recalling 71 Trevo Trak 21 Microcatheter units and related products (TREVO NXT combinations with and without CAT6 configurations). These are medical devices used to place other devices and fluids, such as contrast media, into blood vessels during diagnostic and therapeutic procedures.
The microcatheter product label on the carton is missing the product drawing or illustration. This labeling defect leaves the packaging without the required visual product identification.
The recalled units were distributed worldwide, including to multiple US states (CA, OR, PA, NY, DC, IL, WA, NH, NJ, OK, FL, AZ, AL, GA, TX, WI, VA) and international locations (DE, IT, AT).
The recalled product
- 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…
- Manufacturer
- Stryker Neurovascular
- Affected units
- 71
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (18)
- 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
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