Recall Z-1084-2024— Stryker, Inc.

Name: FDA recall Z-1084-2024
Creator: U.S. Food and Drug Administration
Published: 2023-12-06

Class II · Ongoing

Class II FDA medical device recall by Stryker, Inc., initiated 2023-12-06. It names one FDA 510(k) clearance: K131437. Product: Stryker Neurovascular, Trevo Pro 18 Microcatheter, REF 90238 0.021in X150cm. Reason: The microcatheter IFU contains an intended use that has not been evaluated by the FDA..

Recalling firm: Stryker, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-12-06
Firm location: Salt Lake City, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K131437 — MODIFIED CONCENTRIC MICROCATHETERConcentric Medical, Inc.·cleared 2013-10-11

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

Stryker Neurovascular, Trevo Pro 18 Microcatheter, REF 90238 0.021in X150cm

Reason for recall

The microcatheter IFU contains an intended use that has not been evaluated by the FDA.

Data sourced from openFDA. This site is unofficial and independent of the FDA.