Edwards Lifesciences, LLC: Medical Device Recall in 2023 - (Recall #: Z-0412-2024)

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 with Vamp System, REF: MHD6AZ, MHD6AZ5 , MHD6C502 STIRLEEO, 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-0412-2024

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: 11,072 units

Code Information:

MHD6AZ: UDI:00690103194722, Lot #: 64818047 64858313 64891437 64953982 MHD6AZ5: UDI: 00690103194746, Lot #: 64782419 64882668 64912054 64918246 64933574 64988043 65007223 65007224; MHD6C502: UDI: 00690103194760, Lot #: 64951410

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