FDA Recall
Terminated
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.
Recall: Z-1830-2021
·
Initiated April 21, 2021
Recall
- Recall Number
- Z-1830-2021
- Event Number
- 88024
- Firm
- MICROVENTION INC.
- FEI Number
- 3013556777
- Product Code
- DQY
- Status
- Terminated
- Root Cause
- Labeling Change Control
- Initiated
- April 21, 2021
- Terminated
- February 16, 2024
- Address
- 35 Enterprise, Aliso Viejo, CA, 92656
Description
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.
Reason
Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling.
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.