Recall Z-0990-2025— MICROVENTION INC.

Name: FDA recall Z-0990-2025
Creator: U.S. Food and Drug Administration
Published: 2024-12-02

Class II · Ongoing

Class II FDA medical device recall by MICROVENTION INC., initiated 2024-12-02. It names one FDA 510(k) clearance: K101542. Product: Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846. Reason: Sterility assurance; microcatheter inner packaging may contain incomplete seal..

Recalling firm: MICROVENTION INC.
Classification: Class II
Status: Ongoing
Initiated: 2024-12-02
Firm location: Aliso Viejo, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K101542 — HEADWAY 17 ADVANCED MICROCATHETERMicroVention, Inc.·cleared 2010-08-06

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

Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846

Reason for recall

Sterility assurance; microcatheter inner packaging may contain incomplete seal.

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