FDA Medical Device Recalls (openFDA)
MICROVENTION INC.: 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.
- Recall number
- Z-1828-2021
- Recalling firm
- MICROVENTION INC.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2021-04-21
- Posted
- not on file
- Terminated
- 2024-02-16
- 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
- Quantity
- not on file
- Distribution
- U.S. Nationwide distribution in the states of FL, IA, MI, MN, TN and TX.
- Lot, serial or model codes
- Catalog Number: VIA-17-154-01 UDI: (01)00842429101643(11)190713(17)220630(10)19071320 Lot Number: 19071320 and 20011412PM
- 510(k) numbers
- ["K192135"]
- PMA numbers
- not on file
- Product code
- DQY
- Firm FEI
- 3013556777
- Firm city
- Aliso Viejo
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28