Recall Z-1479-2018— Medtronic Vascular

Name: FDA recall Z-1479-2018
Creator: U.S. Food and Drug Administration
Published: 2018-03-13

Class II · Terminated

Class II FDA medical device recall by Medtronic Vascular, initiated 2018-03-13, terminated 2021-05-07. It names one FDA 510(k) clearance: K161287. Product: Medtronic DxTerity Diagnostic Catheter, JL 4.0, REF DXT5JL40, marked with 6F color code on box.. Reason: 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..

Recalling firm: Medtronic Vascular
Classification: Class II
Status: Terminated
Initiated: 2018-03-13
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 Diagnostic Catheter, JL 4.0, REF DXT5JL40, marked with 6F color code on box.

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.

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