Edwards Lifesciences, LLC: Medical Device Recall in 2021 - (Recall #: Z-1961-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: May 26, 2021

Date Posted: July 7, 2021

Recall Number: Z-1961-2021

Event ID: 87993

Reason for Recall:

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

Status: Terminated

Product Quantity: 290 units

Code Information:

Lot # 63479666- Not Marketed within the US

Distribution Pattern:

US: AZ CA CO CT DC DE FL GA ID IL IN KY LA MA MD ME MI MN MO MS MT NC ND NE NJ PR SD TX UT VA WA WI WV OUS: Canada, United Kingdom, Italy

Voluntary or Mandated:

Voluntary: Firm initiated