Edwards Lifesciences, LLC: Medical Device Recall in 2023 - (Recall #: Z-1380-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 7.5F (2.5mm), Usable Length 110 cm, Recommended Guidewire size 0.018 (0.46mm), Minimum Introducer size 8.5F (2.8 mm)

Product Classification:

Class II

Date Initiated: February 14, 2023

Date Posted: April 19, 2023

Recall Number: Z-1380-2023

Event ID: 91868

Reason for Recall:

There is a potential that the distal end of the catheter may be bent beyond its intended curvature and when connected to patient monitoring device, the monitor may display an error message.

Status: Ongoing

Product Quantity: 326 units

Code Information:

Primary DI Number: 00690103146998/ Lot: 64526520

Distribution Pattern:

US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA RI SC SD TN TX UT VA WA WI WV WY OUS: None

Voluntary or Mandated:

Voluntary: Firm initiated