Edwards Lifesciences, LLC: Medical Device Recall in 2021 - (Recall #: Z-1960-2021)

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 (30 cc)/VAMP Jr/52 in (132 cm) Kit, REF: PXVJ0711, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 07460691954489

Product Classification:

Class II

Date Initiated: May 26, 2021

Date Posted: July 7, 2021

Recall Number: Z-1960-2021

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: 700 units

Code Information:

Lot #s: 63470654, 63505217 and 63592430

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