Recall Z-1908-2024— Stryker Neurovascular

Name: FDA recall Z-1908-2024
Creator: U.S. Food and Drug Administration
Published: 2024-04-23

Class II · Ongoing

Class II FDA medical device recall by Stryker Neurovascular, initiated 2024-04-23. It names one FDA 510(k) clearance: K133177. Product: DAC 044 115cm, Catalog: 90760. 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 record

K133177 — MODIFIED HD GUIDE CATHETERConcentric Medical, Inc.·cleared 2014-02-25

K-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

DAC 044 115cm, Catalog: 90760

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.