Recall Z-0525-2015— Concentric Medical Inc

Name: FDA recall Z-0525-2015
Creator: U.S. Food and Drug Administration
Published: 2013-09-26

Class II · Terminated

Class II FDA medical device recall by Concentric Medical Inc, initiated 2013-09-26, terminated 2014-12-08. It names one FDA 510(k) clearance: K110483. Product: Distal Access Catheter: Model Numbers: 90121, 90130, 90131, 90160. The Distal Access Catheter is intended for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vascular systems.. Reason: Distal Access Catheters were shipped to US customers with the Directions for Use that included instructions for aspiration. This version of the DFU is only approved outside of the US..

Recalling firm: Concentric Medical Inc
Classification: Class II
Status: Terminated
Initiated: 2013-09-26
Terminated: 2014-12-08
Firm location: Mountain View, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K110483 — MODIFIED HD GUIDE CATHETERConcentric Medical, Inc.·cleared 2011-04-04

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

Distal Access Catheter: Model Numbers: 90121, 90130, 90131, 90160. The Distal Access Catheter is intended for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vascular systems.

Reason for recall

Distal Access Catheters were shipped to US customers with the Directions for Use that included instructions for aspiration. This version of the DFU is only approved outside of the US.

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