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.
- Company
- Microvention Inc.
- Recall Initiated
- April 21, 2021
- Terminated
- February 16, 2024
- Recall Number
- Z-1828-2021
- Firm Location
- Aliso Viejo, CA
Reason for Recall
Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling.
Distribution
U.S. Nationwide distribution in the states of FL, IA, MI, MN, TN and TX.
Lot / Code Info
Catalog Number: VIA-17-154-01 UDI: (01)00842429101643(11)190713(17)220630(10)19071320 Lot Number: 19071320 and 20011412PM
Root Cause
Labeling Change Control
Action Taken
On 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
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