Edwards Lifesciences, LLC: Medical Device Recall in 2023 - (Recall #: Z-0409-2024)

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:

Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R5, Rx only, Sterile EO. For use in intravascular pressure monitoring.

Product Classification:

Class II

Date Initiated: October 4, 2023

Date Posted: December 6, 2023

Recall Number: Z-0409-2024

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: 33,327 units

Code Information:

AIQS6: UDI:00690103201079; Lot #s: 64858340 64933520 65027617; AIQS65: UDI:00690103200935; Lot # 64858715; AIQS6R: UDI:00690103201093/Lot #: 64858050 AIQS6R5: UDI:00690103200959/Lot #: 64835570 AIQS8: 00690103201086 UDI:/Lot # 64858150 64858716 64891667 64939370 65179001; AIQS85: UDI:00690103200942/Lot# 64858717 64892324 64892325 64892326 64892327 64904497 64904498 64918260 64918261 64918262 64918263 64918264 64918646 64918647 64918648 64918649 64918650 64918651 64918652 64988038 64988040 65067612; AIQS8R5: 00690103201178/UDI:; Lot # 64817843 64858645 64891410

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