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 TruWave x 2 (3 cc)/VAMP Jr/54 in (136) Kit Recalled by Edwards Lifesciences, LLC Due to There is a potential that the pressure tubing...

Date: May 26, 2021
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

Edwards TruWave x 2 (3 cc)/VAMP Jr/54 in (136) Kit, REF: T443952B, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 57460691930174 ***Not Marketed within the US

Quantity: 290 units

Why Was This Recalled?

There is a potential that the pressure tubing may detach from the blood sampling system

Where Was This Sold?

This product was distributed to 32 states: AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NJ, NC, ND, SD, TX, UT, VA, WA, WV, WI, DC

Affected (32 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