Microvention VIA Microcatheter VIA 21 Recall: International Labeling Differences
Microvention recalls VIA Microcatheter VIA 21 REF VIA-21-154-01 due to international labeling differences that may cause confusion with US-cleared labels.
Lower-risk recall
Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling.
Contact the company
What happened, in plain English
Microvention is recalling a specific type of medical catheter because it was shipped to U.S. customers with international labeling that differs from U.S.-cleared labels. This could cause confusion for healthcare providers using the device. Read more at govinfonow.com/recall/62751-microvention-via-microcatheter-via-21-recall-international-labeling-differences.
Source Summary by GovInfoNow · govinfonow.com/recall/62751-microvention-via-microcatheter-via-21-recall-international-labeling-differences · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1829-2021
Cite this page
“Microvention VIA Microcatheter VIA 21 Recall: International Labeling Differences.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62751-microvention-via-microcatheter-via-21-recall-international-labeling-differences. Based on FDA recall #Z-1829-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1829-2021%22&limit=1).
Why it’s dangerous
The catheter was shipped with international labels that differ from U.S.-cleared labels. This difference could cause confusion for healthcare providers during use, potentially leading to incorrect labeling or procedures.
Who’s affected
Healthcare providers using this catheter in the U.S. are likely affected. Patients receiving the catheter during procedures may be at risk if labeling confusion occurs.
How to tell if you have this one
Check for the catalog number VIA-21-154-01 on the device. The UDI code (01)00842429101650(11)191104(17)221031(10)19110403M and lot number 19110403M are also indicators of the recalled item.
- Brand
Microvention- Product
VIA Microcatheter VIA 21 REF VIA-21-154-01- Category
Medical device
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
U.S. Nationwide distribution in the states of FL, IA, MI, MN, TN and TX.
| Recall number | Product, codes & lots |
|---|---|
| Z-1828-2021 | 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.; Catalog Number: VIA-17-154-01 UDI: (01)00842429101643(11)190713(17)220630(10)19071320 Lot Number: 19071320 and 20011412PM |
| Z-1829-2021 | 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.; Catalog Number: VIA-21-154-01 UDI: (01)00842429101650(11)191104(17)221031(10)19110403M Lot Number: 19110403M |
| Z-1830-2021 | 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.; Catalog Number: VIA-27-154-01 UDI: (01)00842429101667(11)190722(17)220630(10)19072208 Lot Number: 19072208 |
What to do — step by step
Check Device Labeling
Look for the catalog number VIA-21-154-01 and UDI code (01)00842429101650(11)191104(17)221031(10)19110403M on the catheter.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 6 states.
FDA distribution: “U.S. Nationwide distribution in the states of FL, IA, MI, MN, TN and TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Florida, Iowa, Michigan, Minnesota, Tennessee, Texas.
Recall timeline
FDA terminated this recall 2.8 years after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this catheter safe to use?
The recall is due to labeling differences, not safety issues. Healthcare providers can use it as long as they follow proper labeling procedures.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1829-2021 (April 21, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1829-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.