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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90178

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

Open FDA event record

Event summary

Timeline bucket
April 27, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Micro Therapeutics, 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

AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D;

Z-1261-2022
Recall number
Z-1261-2022
Initiated
April 27, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Micro Therapeutics, Inc.
Quantity
96 systems

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to incorrect size and configuration labeling of the detachable coil system.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to incorrect size and configuration labeling of the detachable coil system.

Code information

Product Number: QC-4-12-HELIX UDI-DI (GTIN) Code: 00847536029590 Lot Number: B240079 Product Number: QC-10-30-3D UDI-DI (GTIN) Code: 00847536030138 Lot Number: B240084

Distribution pattern

International distribution in the countries of China and Republic of Korea.