Edwards Lifesciences, LLC: Medical Device Recall in 2015 - (Recall #: Z-1700-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: May 5, 2015

Date Posted: June 10, 2015

Recall Number: Z-1700-2015

Event ID: 71169

Reason for Recall:

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

Status: Terminated

Product Quantity: 978

Code Information:

lot number 59860969.

Distribution Pattern:

Worldwide distribution US nationwide, Canada and Europe (IC, BE, IT, GB, FR, DK, CZ, DE, AT, ES, IE, NO, PL)

Voluntary or Mandated:

Voluntary: Firm initiated