Recall Z-1732-2015— Edwards Lifesciences, LLC

Name: FDA recall Z-1732-2015
Creator: U.S. Food and Drug Administration
Published: 2015-05-18

Class II · Terminated

Class II FDA medical device recall by Edwards Lifesciences, LLC, initiated 2015-05-18, terminated 2015-11-06. It names one FDA 510(k) clearance: K140312. Product: ClearSight, Model No. EVHRS Heart Reference Sensor. The EV1000 Clinical Platform Nl and ClearSight finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters.. Reason: Edward Lifesciences is recalling the ClearSight System because the finger component of the Heart Reference Sensor may be damaged..

Recalling firm: Edwards Lifesciences, LLC
Classification: Class II
Status: Terminated
Initiated: 2015-05-18
Terminated: 2015-11-06
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K140312 — EV1000 CLINICAL PLATFORM WITH CLEARSIGHT TM FINGER CUFF OR CLEARSIGHT TM SYSTEMEdwards Lifesciences, LLC·cleared 2014-06-13

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

ClearSight, Model No. EVHRS Heart Reference Sensor. The EV1000 Clinical Platform Nl and ClearSight finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters.

Reason for recall

Edward Lifesciences is recalling the ClearSight System because the finger component of the Heart Reference Sensor may be damaged.

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