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

VIA Microcatheter VIA recalled by Microvention

Microvention is recalling VIA Microcatheter VIA 17, 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-17-154-01 UDI: (01)00842429101643(11)190713(17)220630(10)19071320 Lot Number: 19071320 and 20011412PM

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-1828-2021
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 17 REF VIA-17-154-01 - 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

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

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

Other products in this recall event

2 other products · FDA event 88024

This product is part of a recall event; the main page for the event is VIA Microcatheter VIA recalled by Microvention.

Reported	Class	Recall	Company	Reason	Where
16 Jun 2021	CLASS III	VIA Microcatheter VIA recalled by Microvention	Microvention	Other	Nationwide
16 Jun 2021	CLASS III	VIA Microcatheter VIA recalled by Microvention	Microvention	Other	Nationwide

More recalls from Microvention

All 38

Reported	Class	Recall	Company	Reason	Where
19 Aug 2026Device	CLASS II	Bobby Balloon Guide Catheter recalled by Microvention	Microvention	Device Malfunction	Nationwide
20 May 2026Device	CLASS II	LVIS Intraluminal Support Device recalled by Microvention	Microvention	Other	CA
22 Oct 2025Device	CLASS II	Flow Re-Direction Endoluminal Devices: FRED recalled by Microvention	Microvention	Other	Nationwide
6 Aug 2025Device	CLASS II	Lifepearl Drug Elutable Microspheres: 200 +/- 50 micrometers recalled	Microvention	Other	GA
19 Feb 2025Device	CLASS II	MicoVention Terumo, LVIS Intraluminal Support Device recalled	Microvention	Other	CA

Other Heart & Vascular Devices recalls

All 6,220

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS II	TufTex¿ Over-the-Wire Embolectomy Catheter recalled	LeMaitre Vascular	Other	Nationwide
14 Oct 2026Device	CLASS II	Endovascular Pack kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6f recalled	Stryker Sustainability Solutions	Particulate Matter	Nationwide
7 Oct 2026Device	CLASS II	Medical convenience kits containing BD CliniClean Pericare recalled	American Contract Systems	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Medical convenience kits containing BD CliniClean Pericare recalled	American Contract Systems	Device Malfunction	Nationwide