Recall Z-1146-2018— Vascular Insights, LLC

Name: FDA recall Z-1146-2018
Creator: U.S. Food and Drug Administration
Published: 2017-11-09

Class II · Terminated

Class II FDA medical device recall by Vascular Insights, LLC, initiated 2017-11-09, terminated 2018-12-18. It names one FDA 510(k) clearance: K071468. Product: ClariVein IC infusion catheter, Model Number: 65-018-E4S Product Usage: The ClariVein IC infusion catheter is indicated for infusion of physician-specified agents into the peripheral vasculature.. Reason: Certain catheters could have a compromised catheter shaft due to a manufacturing defect which could result in some delamination of the catheter shaft including during introduction of the catheter into a vascular access introducer..

Recalling firm: Vascular Insights, LLC
Classification: Class II
Status: Terminated
Initiated: 2017-11-09
Terminated: 2018-12-18
Firm location: Quincy, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K071468 — CLARIVEIN CATHETERVascular Insights, LLC·cleared 2008-03-20

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

ClariVein IC infusion catheter, Model Number: 65-018-E4S Product Usage: The ClariVein IC infusion catheter is indicated for infusion of physician-specified agents into the peripheral vasculature.

Reason for recall

Certain catheters could have a compromised catheter shaft due to a manufacturing defect which could result in some delamination of the catheter shaft including during introduction of the catheter into a vascular access introducer.

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