Recall Z-3253-2018— Medtronic Vascular

Name: FDA recall Z-3253-2018
Creator: U.S. Food and Drug Administration
Published: 2018-08-16

Class III · Terminated

Class III FDA medical device recall by Medtronic Vascular, initiated 2018-08-16, terminated 2021-05-07. It names one FDA 510(k) clearance: K161287. Product: Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35. Reason: 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..

Recalling firm: Medtronic Vascular
Classification: Class III
Status: Terminated
Initiated: 2018-08-16
Terminated: 2021-05-07
Firm location: Danvers, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K161287 — DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-PakMedtronic Vascular·cleared 2016-08-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.