Edwards Lifesciences, LLC: Medical Device Recall in 2021 - (Recall #: Z-1959-2021)

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 (3 cc)/VAMP Jr 48 in (120 cm) Kit, REF: PXVJ356, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 57460691954507

Product Classification:

Class II

Date Initiated: May 26, 2021

Date Posted: July 7, 2021

Recall Number: Z-1959-2021

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: 460 units

Code Information:

Lot #s: 63505216 and 63590087

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