VirtuTRAX Instrument Navigator recallZ-0395-2022 · Civco Medical Instruments Co. Inc. · initiated Oct 8, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Civco Medical Instruments Co. Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.
FDA root cause category: Device Design
What the company is doing
The firm distributed an "URGENT: MEDICAL DEVICE RECALL" notice on 10/21/2021 by email. The notice explained the problem and requested acknowledgement of the notice. Entities further distributing the products were directed to notify those to whom the devices were distributed. The firm will be replacing the units.
Recall details
- Recall number
- Z-0395-2022
- Status
- Terminated
- Initiated by the company
- Oct 8, 2021
- Recalling firm
- Civco Medical Instruments Co. Inc.
- Quantity
- 52 boxes (5 units/box)
- Product code
- IYO
- FDA submissions
- K092619
- Distribution
- Worldwide distribution - US Nationwide and the countries of Belgium, Canada, China (Mainland), China (Taiwan), Denmark, France, Germany, Italy, Japan, Netherlands, Singapore, South Korea, Spain, Thailand.
Product description
VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX
Code information (models, lots, serial numbers)
Part Number 5350925; UDI 00841436100892; Lot Numbers: A117795, A119539, A121993, A129844, A131074, A131075, A131690, A142178
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- VirtuTRAX Instrument Navigator 5350925Civco Medical Instruments CO., Inc. · System, imaging, pulsed echo, ultrasonic1 recall0 reports
Product lines
Other devices under the same FDA submission
11 devices cleared under K092619 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- VirtuTRAX Instrument Navigator 610-1080Civco Medical Instruments CO., Inc. · System, imaging, pulsed echo, ultrasonic1 recall0 reports
- eTRAX™ Needle System Starter Kit 667-149Civco Medical Instruments CO., Inc. · System, imaging, pulsed echo, ultrasonic1 recall0 reports
- eTRAX™ Needle System Starter Kit 667-150Civco Medical Instruments CO., Inc. · System, imaging, pulsed echo, ultrasonic1 recall0 reports
- eTRAX™ Needle System Starter Kit 667-151Civco Medical Instruments CO., Inc. · System, imaging, pulsed echo, ultrasonic1 recall0 reports
- eTRAX™ Needle System Starter Kit 667-152Civco Medical Instruments CO., Inc. · System, imaging, pulsed echo, ultrasonic1 recall0 reports
- eTRAX™ Needle Sensor 667-156Civco Medical Instruments CO., Inc. · System, imaging, pulsed echo, ultrasonic1 recall0 reports
- eTRAX™ Needle Sensor 667-157Civco Medical Instruments CO., Inc. · System, imaging, pulsed echo, ultrasonic1 recall0 reports
- eTRAX™ Needle Sensor 667-158Civco Medical Instruments CO., Inc. · System, imaging, pulsed echo, ultrasonic1 recall0 reports
- eTRAX™ Needle Sensor 667-159Civco Medical Instruments CO., Inc. · System, imaging, pulsed echo, ultrasonic1 recall0 reports
- VirtuTRAX Instrument Navigator 610-1059Civco Medical Instruments CO., Inc. · System, imaging, pulsed echo, ultrasonic1 recall0 reports
- VirtuTRAX Instrument Navigator 610-1153Civco Medical Instruments CO., Inc. · System, imaging, pulsed echo, ultrasonic1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 88906).
- Z-0396-2022 · TerminatedVirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX
- Z-0397-2022 · TerminatedVirtuTRAX Instrument Navigator, Sensor with 10 17 GA VirtutTRAX
- Z-0398-2022 · TerminatedVirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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