Exact FDA event identifier

Event 95962

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: December 02, 2024
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: MICROVENTION INC.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-0990-2025

Recall number: Z-0990-2025
Initiated: December 02, 2024
Classification: Class II
Status: Ongoing
Recalling firm: MICROVENTION INC.
Quantity: 107 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

incomplete seal

Sterility assurance reason.sterility_assurance · v1.0.0

Sterility assurance; microcatheter inner packaging may contain incomplete

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility assurance; microcatheter inner packaging may contain incomplete seal.

Code information

Lot # 0000629846/UDI: (01)00816777027634

Distribution pattern

US: None OUS: China