Class II — Potential Health Hazard

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

Pressure Monitoring sets with VAMP Plus closed blood sampling system Recalled by Edwards Lifesciences, LLC Due to The device is being recalled because the firm...

Date: January 30, 2013
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

Pressure Monitoring sets with VAMP Plus closed blood sampling system model # T001691A, PXVP0566, PXVP2260, PXVP0826, PXVP0827, PXVP2284AT3, PXVP23X3AT3, T398807D, T100605B, T001762A, T391T00A, VP2. Blood sampling system used on patients requiring periodic withdrawal of blood samples.

Quantity: 30,467

Why Was This Recalled?

The device is being recalled because the firm has received multiple complaints related to incorrect assembly that may result in dilution of blood samples.

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