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U.S. Department of Health and Human Services

Class 3 Device Recall VIA Microcatheter

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 Class 3 Device Recall VIA Microcathetersee related information
Date Initiated by FirmApril 21, 2021
Create DateJune 07, 2021
Recall Status1 Terminated 3 on February 16, 2024
Recall NumberZ-1829-2021
Recall Event ID 88024
510(K)NumberK192135 
Product Classification Catheter, percutaneous - Product Code DQY
ProductVIA 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.
Code Information Catalog Number: VIA-21-154-01 UDI: (01)00842429101650(11)191104(17)221031(10)19110403M Lot Number: 19110403M
Recalling Firm/
Manufacturer		 MICROVENTION INC.
35 Enterprise
Aliso Viejo CA 92656
For Additional Information ContactIrina Kulinets, Ph.D.
714-247-8159
Manufacturer Reason
for Recall		Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling.
FDA Determined
Cause 2		Labeling Change Control
ActionOn 04/30/ 2021, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Notification Letter via mail/hand delivery/phone to customers informing them that a limited-quantity of microcatheters with international labeling, which has some differences with US-cleared labeling, was inadvertently shipped to U.S. customers
DistributionU.S. Nationwide distribution in the states of FL, IA, MI, MN, TN and TX.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DQY
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