Class II — Potential Health Hazard

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

Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer. A Recalled by Edward Lifesciences, Llc Due to Flow restriction issues in a trifurcated IV set...

Date: July 31, 2015
Company: Edward 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 Edward Lifesciences, Llc directly.

Affected Products

Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer. A sterile, single-use kit that monitors pressures when attached to pressure monitoring catheters. For use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring.

Quantity: 13,077 (U.S.) and 12,306 (International)

Why Was This Recalled?

Flow restriction issues in a trifurcated IV set included in the pressure transducer kits. A restriction of the flow of IV fluid would result in either an inability to prime the system before use or difficulty in flushing the line after a blood draw.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Edward Lifesciences, Llc

Edward Lifesciences, Llc has 1 total recall tracked by RecallDetector.

Related Recalls

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