Z-1479-2018Class II

Medtronic DxTerity Diagnostic Catheter, JL 4.0, REF DXT5JL40, marked with 6F color code on box

Name: Z-1479-2018 Medtronic DxTerity Diagnostic Catheter, JL 4.0, REF DXT5JL40, marked with 6F color code on box
Creator: Medtronic Vascular
Published: 2018-03-13
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2018-03-13 / Terminated / root cause: packaging

FDA source

Medtronic Vascular began a recall of Medtronic DxTerity Diagnostic Catheter, JL 4.0, REF DXT5JL40, marked with 6F color code on box on 2018-03-13. FDA classified it as Class II and gives the reason as "The color coded French size indicator on the outer box may incorrectly reflect a 6 French size, rather than the correct 5 French size. The catheters inside the carton are the correct DXT5JL40 item, the inner pouch has...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1479-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-13
Posted: 2018-04-20
Terminated: 2021-05-07
Recalling firm: Medtronic, Inc.
Product: Medtronic DxTerity Diagnostic Catheter, JL 4.0, REF DXT5JL40, marked with 6F color code on box.
Product code: DQO Catheter, Intravascular, Diagnostic
Reason for recall: The color coded French size indicator on the outer box may incorrectly reflect a 6 French size, rather than the correct 5 French size. The catheters inside the carton are the correct DXT5JL40 item, the inner pouch has correct 5F labeling, information and configuration details.
Root cause tag: packaging
FDA root cause: Packaging
Action: Medtronic initiated consignee communications on 13-Mar- 2018 to Risk Managers and Health Care Professionals. US notifications were sent via 2-Day UPS delivery. OUS communications were sent per locally approved methods. Consignees are asked to quarantine and return any unused potentially affected product to Medtronic.
Quantity in commerce: 855 units
Distribution: US and AUSTRIA, Canada, Germany, ROMANIA, SLOVENIA,
Product codes and lots: UDI 20643169689309, Lot Number 60074805

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1479-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1479-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-02	2018-04-20

Product code DQO

K161287Class IIDxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-PakMedtronic Vascular / cleared 2016-08-19

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)