Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Oxymetry Cable Recalled by Edwards Lifesciences, LLC Due to Intermittent communication due to inconsistent crimping of connectors...

Date: October 7, 2019
Company: Edwards Lifesciences, LLC
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Edwards Lifesciences, LLC directly.

Affected Products

Oxymetry Cable, Rxonly. REF/UDI: HEMOXSC100/(01)00690103196986 - Product Usage: The HemoSphere oximetry cable is a multi-use device that connects with a compatible Edwards monitor on one end and any approved Edwards oximetry catheter on the other end to continuously measure venous oxygen saturation.

Quantity: 35

Why Was This Recalled?

Intermittent communication due to inconsistent crimping of connectors onto cables.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Edwards Lifesciences, LLC

Edwards Lifesciences, LLC has 94 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report