Recall Z-1207-2018— Medtronic Inc

Name: FDA recall Z-1207-2018
Creator: U.S. Food and Drug Administration
Published: 2017-09-26

Class I · Terminated

Class I FDA medical device recall by Medtronic Inc, initiated 2017-09-26, terminated 2021-04-27. It names one FDA 510(k) clearance: K083422. Product: 6F Taiga Guiding Catheter. Reason: Complaints regarding 6F Taiga guide catheter tip detachment and/or tip splitting..

Recalling firm: Medtronic Inc
Classification: Class I
Status: Terminated
Initiated: 2017-09-26
Terminated: 2021-04-27
Firm location: Minneapolis, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K083422 — 6F TAIGA GUIDING CATHETERMedtronic Vascular·cleared 2009-02-06

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

6F Taiga Guiding Catheter

Reason for recall

Complaints regarding 6F Taiga guide catheter tip detachment and/or tip splitting.

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