Microvention recalls VIA Microcatheter VIA 17 REF VIA-17-154-01 due to international labeling differences that may cause confusion with US-cleared versions.
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 labeling that has differences from U.S.-cleared labels. This could cause confusion for healthcare providers but does not pose a direct safety risk during normal use.
Healthcare providers using the VIA Microcatheter VIA 17 REF VIA-17-154-01 may be affected. Patients receiving this device are at low risk since the labeling difference is not a direct safety hazard.
Check for the catalog number VIA-17-154-01 and lot numbers 19071320 or 20011412PM. The device is a single lumen catheter designed for vascular procedures.
Verify the labeling matches U.S.-cleared versions to ensure correct use.
No, the labeling difference does not pose a direct safety risk during normal use.
Look for catalog number VIA-17-154-01 and lot numbers 19071320 or 20011412PM.
No, the recall is for labeling clarification, not a safety hazard.
We’ve drafted a message you can send Microvention to request your refund or repair — edit it as you like.
Subject: Recall Z-1828-2021 — Microvention Microvention Hello, I own a Microvention that is covered by recall Z-1828-2021 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.