Z-1408-2015Class II

VasoNova Vascular Positioning System (VPS ) G4 Console Catalog number VPS-G4C Cardiovascular: The VPS Stylet...

Name: Z-1408-2015 VasoNova Vascular Positioning System (VPS ) G4 Console Catalog number VPS-G4C Cardiovascular: The VPS Stylet...
Creator: VasoNova, Inc.
Published: 2015-03-30
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2015-03-30 / Terminated / root cause: design

FDA source

VasoNova, Inc. began a recall of VasoNova Vascular Positioning System (VPS ) G4 Console Catalog number VPS-G4C Cardiovascular: The VPS Stylet and Console are indicated for guidance and tip... on 2015-03-30. FDA classified it as Class II and gives the reason as "A limited number of VPS G4 Consoles are being recalled due to noncompliance with International Electrotechnical Commission Standard 60101-1-1". 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-1408-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-30
Posted: 2015-04-09
Terminated: 2016-04-11
Recalling firm: Teleflex Medical
Product: VasoNova Vascular Positioning System (VPS ) G4 Console Catalog number VPS-G4C Cardiovascular: The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters.
Product code: OBJ Catheter, Ultrasound, Intravascular
Reason for recall: A limited number of VPS G4 Consoles are being recalled due to noncompliance with International Electrotechnical Commission Standard 60101-1-1.
Root cause tag: design
FDA root cause: Device Design
Action: Teleflex sent an Urgent Medical Device Recall Notification letters dated on March 30, 2015 to all affected customers. The letters identified the affected product, problem and actions to be taken. The risk to users is identified and users are asked to discontinue use and quarantine affected serial numbers. Teleflex sales reps will help with return of product. The Acknowledgeable form should be completed and returned as per instructions. Questions should be directed to 1.877.236.6869.
Quantity in commerce: 17
Distribution: US Nationwide Distribution in the states of AZ, DC, PA, IN, PA. GA, NY, KS, CA, VA, NC.
Product codes and lots: Product code VPS-G4C; Serial numbers: GB40129, GB40130, GB40131, GB40133, GB40136, GB40146, GB40148, GB40151, GB40152, GB40154, GB40155, GB401456, GB40157, GB40158, GB40168, GB40175, GB40186

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1408-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1408-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-15	2015-04-09

Product code OBJ

K123813Class IIVascular Positioning System (Vps) G4 ConsoleVasonova, Inc. / cleared 2013-01-18

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)