Z-0398-2022Class II

VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX

Name: Z-0398-2022 VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX
Creator: Civco Medical Instruments Co. Inc.
Published: 2021-10-08
License: https://open.fda.gov/license/

CIVCO Medical Instruments Co., Inc. / initiated 2021-10-08 / Terminated / root cause: design

FDA source

Civco Medical Instruments Co. Inc. began a recall of VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX on 2021-10-08. FDA classified it as Class II and gives the reason as "There is potential that the VirtuTRAX device will not tighten onto the instrument to be used". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0398-2022
Classification: Class II
Status: Terminated
Initiated: 2021-10-08
Posted: 2021-12-20
Terminated: 2024-09-30
Recalling firm: CIVCO Medical Instruments Co., Inc.
Product: VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX
Product code: IYO System, Imaging, Pulsed Echo, Ultrasonic
Reason for recall: There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 599 boxes (5 units/box)
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 codes and lots: Part Number 610-1059; UDI 00841436101882 Lot Numbers: A108295, A111466, A111759, A112392, A113288, A113874, A116720, A118295, A118557, A119369, A120039, A120344, A120567, A120641, A120807, A121367, A121506, A121516, A121866, A122103, A123138, A124555, A125980, A127569, A127842, A129198, A129948, A129949, A129950, A130252, A131213, A131428, A132258, A132471, A133741, A133742, A133823, A134199, A134203, A135587, A135846, A136274, A136787, A137788, A138199, A138307, A138805, A139478, A140029, A140660, A142719, A143236, A144157, A144317, A144992, A145774

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0398-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0395-2022	Class II	Terminated	Voluntary: Firm initiated	2021-12-29	2021-12-20
Z-0396-2022	Class II	Terminated	Voluntary: Firm initiated	2021-12-29	2021-12-20
Z-0397-2022	Class II	Terminated	Voluntary: Firm initiated	2021-12-29	2021-12-20
Z-0398-2022	Class II	Terminated	Voluntary: Firm initiated	2021-12-29	2021-12-20

Product code IYO

K092619Class IIEtrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax Universal TrackerCivco / cleared 2009-11-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)