Recall Z-1747-2020— Vascular Solutions, Inc.

Name: FDA recall Z-1747-2020
Creator: U.S. Food and Drug Administration
Published: 2020-03-16

Class I · Terminated

Class I FDA medical device recall by Vascular Solutions, Inc., initiated 2020-03-16, terminated 2024-06-18. It names one FDA 510(k) clearance: K051395. Product: Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies. Reason: The inner lumen of the Langston catheter may separate from the hub during pressure injection..

Recalling firm: Vascular Solutions, Inc.
Classification: Class I
Status: Terminated
Initiated: 2020-03-16
Terminated: 2024-06-18
Firm location: Maple Grove, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K051395 — LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETERVascular Solutions, Inc.·cleared 2005-06-24

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

Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies

Reason for recall

The inner lumen of the Langston catheter may separate from the hub during pressure injection.

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