Recall Z-1700-2015— Edwards Lifesciences, LLC

Name: FDA recall Z-1700-2015
Creator: U.S. Food and Drug Administration
Published: 2015-05-05

Class II · Terminated

Class II FDA medical device recall by Edwards Lifesciences, LLC, initiated 2015-05-05, terminated 2016-10-17. It names one FDA 510(k) clearance: K940795. Product: Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75. Flow-directed pulmonary artery catheters for monitoring cardiac output, mixed venous oxygen saturation, and end diastolic volume when used with the Vigilance Monitor.. Reason: The product failed to meet the internal established statistical test requirement for heparin activity..

Recalling firm: Edwards Lifesciences, LLC
Classification: Class II
Status: Terminated
Initiated: 2015-05-05
Terminated: 2016-10-17
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K940795 — SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETERBaxter Edwards·cleared 1994-05-24

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

Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75. Flow-directed pulmonary artery catheters for monitoring cardiac output, mixed venous oxygen saturation, and end diastolic volume when used with the Vigilance Monitor.

Reason for recall

The product failed to meet the internal established statistical test requirement for heparin activity.

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