CLASS III Device recall · Reported 16 Jun 2021 · FDA Enforcement Report

VIA Microcatheter VIA recalled by Microvention

Microvention is recalling VIA Microcatheter VIA 27, distributed nationwide in the US. The recall was initiated on 21 Apr 2021 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesCatalog Number: VIA-27-154-01 UDI: (01)00842429101667(11)190722(17)220630(10)19072208 Lot Number: 19072208

Quantity recalledN/A

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1830-2021
FDA event ID: 88024
Recalling firm: Microvention, Aliso Viejo, CA
Classification: Class III
Status: Terminated
Recall initiated: 21 Apr 2021
FDA classified: 7 Jun 2021
Reported: 16 Jun 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

21 Apr 2021	Recall initiated by company
7 Jun 2021	Classified by FDA	+47 days
16 Jun 2021	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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.

Where it was distributed

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

Nationwide Florida Iowa Michigan Minnesota Tennessee Texas

Questions about this recall

Is VIA Microcatheter VIA 27 recalled?

Yes. Microvention recalled VIA Microcatheter VIA 27 on 21 Apr 2021. The recall is Class III and its status is Terminated. Recall number Z-1830-2021.

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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