Trevo Trak 21 Microcatheter Distributed with Incorrect Instructions and Labels
Stryker Neurovascular is recalling Trevo Trak 21 Microcatheters because Out-of-US approved instructions and labels were distributed instead of US-approved versions. Affected customers in CA and VA should contact the manufacturer.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Risk-of-harm product (medical device with incorrect instructions for use) where no injuries have been reported. CLASS II FDA classification indicates potential for adverse health consequences.
Plain-English summary
Stryker Neurovascular is recalling Trevo Trak 21 Microcatheters that were distributed with Out-of-United States (OUS) approved Instructions for Use (IFU) and packaging labels instead of United States approved versions. Six units were identified among customers in California and Virginia, with lot numbers 0000590444 and 0000603275.
The devices were shipped with documentation that does not meet US regulatory requirements. OUS-approved materials have different configurations from US-approved versions and should not have been distributed to US customers.
Customers who received these affected lot numbers should contact Stryker Neurovascular regarding the recall.
The recalled product
- Product
- 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…
- Manufacturer
- Stryker Neurovascular
- Category
- Medical Device — Neurovascular
- Hazard
- Affected units
- 6
Distribution
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