Recall Z-1830-2021 ยท DQY Catheter, Percutaneous
MICROVENTION INC.
VIA Microcatheter VIA 27 REF VIA-27-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewire into the vasculature.
| Date | Apr 21, 2021 |
| Status | Terminated |
| Reason | Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling. |
| Root cause | Labeling Change Control |
| Action | 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 |
| Distribution | U.S. Nationwide distribution in the states of FL, IA, MI, MN, TN and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192135 | VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27), VIA Microcatheter (size 33) MicroVention, Inc., Dec 24, 2019 |