Microvention recalls VIA Microcatheter VIA 27 REF VIA-27-154-01 due to international labeling differences that may confuse U.S. customers. This is a single lumen catheter used in medical procedures.
Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling.
Microvention is recalling a specific medical catheter model because it was shipped to U.S. customers with international labeling that differs from U.S.-cleared labeling. This could cause confusion for healthcare providers using the device.
The catheter was shipped with international labeling that has differences from U.S.-cleared labeling. This could lead to confusion for healthcare providers during medical procedures, but it does not cause physical harm directly.
Healthcare providers who use this specific catheter model in medical procedures may be affected. Patients receiving the device are not directly at risk from the labeling difference.
Check for the product name 'VIA Microcatheter VIA 27' and catalog number VIA-27-154-01. The device was sold internationally and shipped to U.S. customers with labeling differences.
Verify if the device has international labeling that differs from U.S.-cleared labeling.
No, the labeling difference does not cause physical harm. It may cause confusion for healthcare providers but is not a safety hazard.
No, the recall is for labeling differences, not a safety issue. Healthcare providers can continue using the device if they confirm the labeling matches U.S. standards.
Look for the catalog number VIA-27-154-01 and check if the device has international labeling that differs from U.S.-cleared labeling.
We’ve drafted a message you can send Microvention to request your refund or repair — edit it as you like.
Subject: Recall Z-1830-2021 — Microvention Microvention Hello, I own a Microvention that is covered by recall Z-1830-2021 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.