Device product
VIA Microcatheter VIA 21 REF VIA-21-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewire into the vasculature.
Z-1829-2021
Product summary
- Event
- Event 88024
- Status
- Terminated
- Classification
- Class III
- Quantity
- N/A
- Official record key
device-enforcement:Z-1829-2021
Official wording
Reason: Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling.
Code information: Catalog Number: VIA-21-154-01 UDI: (01)00842429101650(11)191104(17)221031(10)19110403M Lot Number: 19110403M
Distribution pattern: U.S. Nationwide distribution in the states of FL, IA, MI, MN, TN and TX.
Derived failure modes
-
Unknown
Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling.