Reported Jun 16, 2021 · Terminated
VIA Microcatheter VIA 27 REF VIA-27-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a…
Microvention Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: MICROVENTION INC. · 35 Enterprise · Aliso Viejo, CA · 92656
Is this the product you have?
- VIA Microcatheter VIA 27
- REF VIA-27-154-01 - Product Usageis a single lumen catheter designed to be introduced over a steerable guidewire into the vasculature
- Lot codes and dates
- Catalog NumberVIA-27-154-01
- UDI(01)00842429101667(11)190722(17)220630(10)19072208
- Lot Number19072208
- Amount recalled
- N/A
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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