MICROVENTION INC.: Medical Device Recall in 2025 - (Recall #: Z-0990-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: December 2, 2024

Date Posted: January 29, 2025

Recall Number: Z-0990-2025

Event ID: 95962

Reason for Recall:

Sterility assurance; microcatheter inner packaging may contain incomplete seal.

Status: Ongoing

Product Quantity: 107 units

Code Information:

Lot # 0000629846/UDI: (01)00816777027634

Distribution Pattern:

US: None OUS: China

Voluntary or Mandated:

Voluntary: Firm initiated