Microvention recalls VIA Microcatheter VIA 21 REF VIA-21-154-01 due to international labeling differences that may cause confusion with US-cleared labels.
Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling.
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.
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.
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.
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.
Look for the catalog number VIA-21-154-01 and UDI code (01)00842429101650(11)191104(17)221031(10)19110403M on the catheter.
The recall is due to labeling differences, not safety issues. Healthcare providers can use it as long as they follow proper labeling procedures.
Check the device for the catalog number VIA-21-154-01 and UDI code. If you have it, contact Microvention for guidance.
The recall does not mention any injury risk. The hazard is labeling confusion, not physical harm.
We’ve drafted a message you can send Microvention to request your refund or repair — edit it as you like.
Subject: Recall Z-1829-2021 — Microvention Microvention Hello, I own a Microvention that is covered by recall Z-1829-2021 from Microvention. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
