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.
Reported: June 16, 2021 Initiated: April 21, 2021 #Z-1828-2021
Product Description
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.
Reason for Recall
Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling.
Details
- Recalling Firm
- MICROVENTION INC.
- Units Affected
- N/A
- Distribution
- U.S. Nationwide distribution in the states of FL, IA, MI, MN, TN and TX.
- Location
- Aliso Viejo, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by MICROVENTION INC.. Units affected: N/A.
Why was this product recalled? ▼
Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 16, 2021. Severity: Low. Recall number: Z-1828-2021.
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