Z-3253-2018Class III

Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35

Name: Z-3253-2018 Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35
Creator: Medtronic Vascular
Published: 2018-08-16
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2018-08-16 / Terminated / root cause: labeling and UDI

FDA source

Medtronic Vascular began a recall of Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35 on 2018-08-16. FDA classified it as Class III and gives the reason as "Medtronic has determined that the French size indicator on the inner pouch may incorrectly reflect a 6 French size, rather than the correct 5 French size. The catheters inside the pouch are the correct U5TRAN35 item...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-3253-2018
Classification: Class III
Status: Terminated
Initiated: 2018-08-16
Posted: 2018-09-26
Terminated: 2021-05-07
Recalling firm: Medtronic, Inc.
Product: Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35
Product code: DQO Catheter, Intravascular, Diagnostic
Reason for recall: Medtronic has determined that the French size indicator on the inner pouch may incorrectly reflect a 6 French size, rather than the correct 5 French size. The catheters inside the pouch are the correct U5TRAN35 item, the outer carton has all the correct labeling, and all the other information and configuration details on both the carton and the pouch are correct.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Medtronic initiated consignee communications on 16-Aug-2018 to Risk Managers and Health Care Professionals. US notifications were sent via 2-Day UPS delivery. Consignees are asked to quarantine and return any unused potentially affected product to Medtronic.
Quantity in commerce: 250 units
Distribution: CA, IA, NE, TN, TX, VA, WA, Jamaica, New Zealand, Thailand
Product codes and lots: UDI/GTIN: 20643169738717 Lot Number 60068186

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3253-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3253-2018	Class III	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-26

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)