Edwards Lifesciences, LLC: Medical Device Recall in 2023 - (Recall #: Z-0411-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

FloTrac Sensor, REF: MHD8 & MHD85,MHD6R5, MHD8R, MHD8R5, MHD8S, STERILEEO, Rx only. For use in intravascular pressure monitoring.

Product Classification:

Class II

Date Initiated: October 4, 2023

Date Posted: December 6, 2023

Recall Number: Z-0411-2024

Event ID: 93279

Reason for Recall:

Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.

Status: Ongoing

Product Quantity: 1417 units

Code Information:

MHD8: UDI: 00690103194609/ Lot # 64874824, 64886991, 64897466, 64982736; MHD85: UDI: 00690103194616/ Lot # 64858315; MHD6R5: UDI:07460691949737/Lot # 65008717, 65008718; MHD8R: UDI: 07460691949829/Lot # 64892236, 65009105; MHD8R5: UDI:07460691949744/Lot # 64886927; MHD8S: UDI: 07460691949805/Lot # 65048926

Distribution Pattern:

US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA WA WI WV WY OUS: Argentina Australia Austria Bahrain Belgium Brazil Canada CANARY ISLANDS Chile Colombia Costa Rica Czech Republic Denmark Ecuador Faroe Islands France Germany Greece Guatemala Hong Kong Indonesia Ireland Israel Italy Japan Malaysia Netherlands New Zealand Northern Ireland Norway Panama Poland Portugal Saudi Arabia Singapore Slovakia Slovenia South Korea Spain Sweden Switzerland United Arab Emirates (UAE) United Kingdom Vietnam

Voluntary or Mandated:

Voluntary: Firm initiated