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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88024

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 21, 2021
Product types
Device
Classifications
Class III
Statuses
Terminated
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

3 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 3

VIA Microcatheter VIA 17 REF VIA-17-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewire into the vasculature.

Z-1828-2021
Recall number
Z-1828-2021
Initiated
April 21, 2021
Classification
Class III
Status
Terminated
Recalling firm
MICROVENTION INC.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling.

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 inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling.

Code information

Catalog Number: VIA-17-154-01 UDI: (01)00842429101643(11)190713(17)220630(10)19071320 Lot Number: 19071320 and 20011412PM

Distribution pattern

U.S. Nationwide distribution in the states of FL, IA, MI, MN, TN and TX.

device · product 2 of 3

VIA Microcatheter VIA 21 REF VIA-21-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewire into the vasculature.

Z-1829-2021
Recall number
Z-1829-2021
Initiated
April 21, 2021
Classification
Class III
Status
Terminated
Recalling firm
MICROVENTION INC.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling.

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 inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling.

Code information

Catalog Number: VIA-21-154-01 UDI: (01)00842429101650(11)191104(17)221031(10)19110403M Lot Number: 19110403M

Distribution pattern

U.S. Nationwide distribution in the states of FL, IA, MI, MN, TN and TX.

device · product 3 of 3

VIA Microcatheter VIA 27 REF VIA-27-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewire into the vasculature.

Z-1830-2021
Recall number
Z-1830-2021
Initiated
April 21, 2021
Classification
Class III
Status
Terminated
Recalling firm
MICROVENTION INC.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling.

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 inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling.

Code information

Catalog Number: VIA-27-154-01 UDI: (01)00842429101667(11)190722(17)220630(10)19072208 Lot Number: 19072208

Distribution pattern

U.S. Nationwide distribution in the states of FL, IA, MI, MN, TN and TX.