Z-1828-2021Class III

VIA Microcatheter VIA 17 REF VIA-17-154-01 -

Name: Z-1828-2021 VIA Microcatheter VIA 17 REF VIA-17-154-01 -
Creator: Microvention Inc.
Published: 2021-04-21
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2021-04-21 / Terminated / root cause: labeling and UDI

FDA source

MICROVENTION INC. began a recall of 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 on 2021-04-21. FDA classified it as Class III and gives the reason as "Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1828-2021
Classification: Class III
Status: Terminated
Initiated: 2021-04-21
Posted: 2021-06-07
Terminated: 2024-02-16
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: 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.
Product code: DQY Catheter, Percutaneous
Reason for recall: Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: On 04/30/ 2021, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Notification Letter via mail/hand delivery/phone to customers informing them that a limited-quantity of microcatheters with international labeling, which has some differences with US-cleared labeling, was inadvertently shipped to U.S. customers
Distribution: U.S. Nationwide distribution in the states of FL, IA, MI, MN, TN and TX.
Product codes and lots: Catalog Number: VIA-17-154-01 UDI: (01)00842429101643(11)190713(17)220630(10)19071320 Lot Number: 19071320 and 20011412PM

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1828-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1828-2021	Class III	Terminated	Voluntary: Firm initiated	2021-06-16	2021-06-07
Z-1829-2021	Class III	Terminated	Voluntary: Firm initiated	2021-06-16	2021-06-07
Z-1830-2021	Class III	Terminated	Voluntary: Firm initiated	2021-06-16	2021-06-07

Product code DQY

K192135Class IIVIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27), VIA Microcatheter (size 33)MicroVention, Inc. / cleared 2019-12-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)