Recall Z-1906-2024— Stryker Neurovascular
Class II · Ongoing
Class II FDA medical device recall by Stryker Neurovascular, initiated 2024-04-23. It names one FDA 510(k) clearance: K211594. Product: Trevo Trak 21 Microcatheter, Catalog: 90338. Reason: Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis..
- Recalling firm
- Stryker Neurovascular
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-04-23
- Firm location
- Fremont, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Trevo Trak 21 Microcatheter, Catalog: 90338
Reason for recall
Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.
Data sourced from openFDA. This site is unofficial and independent of the FDA.