Recall Z-1248-2021— Medtronic Vascular

Name: FDA recall Z-1248-2021
Creator: U.S. Food and Drug Administration
Published: 2021-01-15

Class II · Terminated

Class II FDA medical device recall by Medtronic Vascular, initiated 2021-01-15, terminated 2023-06-15. It names one FDA 510(k) clearance: K021256. Product: Medtronic 6F Launcher Guide Catheter 100 cm EBU 3.0 Model Number: LA6EBU30. Reason: Sterility may be compromised due to an unsealed pouch.

Recalling firm: Medtronic Vascular
Classification: Class II
Status: Terminated
Initiated: 2021-01-15
Terminated: 2023-06-15
Firm location: Danvers, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K021256 — Z3 GUIDE CATHETERMedtronic Vascular·cleared 2002-05-17

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 6F Launcher Guide Catheter 100 cm EBU 3.0 Model Number: LA6EBU30

Reason for recall

Sterility may be compromised due to an unsealed pouch

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