FDA Medical Device Recalls (openFDA)
Edwards Lifesciences, LLC: Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R5, Rx only, Sterile EO. For use in intravascular pressure monitoring.
- Recall number
- Z-0409-2024
- Recalling firm
- Edwards Lifesciences, LLC
- Product
- Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R5, Rx only, Sterile EO. For use in intravascular pressure monitoring.
- Status
- Open, Classified
- Initiated
- 2023-10-04
- Posted
- 2023-11-29
- Terminated
- not on file
- Reason
- Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
- Root cause
- Device Design
- Action
- On 10/18/2023, Edwards Lifesciences issued a "Urgent: Medical device Correction Action via FedEx mail. Edwards ask consignees to take the following actions: 1. Follow the IFU for proper setup and flushing of your device. 2. Follow the instructions included in the enclosed customer acknowledgement form to complete the acknowledgement process. 3. Verify your inventory on the attached customer acknowledgement form. 3a.E-mail the completed form to Edwards Customer Service at US.FCA@edwards.com, within 15 days from receipt of this notification. 4. Distribute this notice within your organization or to any organization where the potentially impacted product has been transferred. 5. Please post a copy of this notice near and/or with affected devices. 6. Contact Edwards Customer Service at 1-888-352-0904 if you would like to return any of your devices or have further questions. 7. Action Requested for Distributors: In addition to the actions above, please forward this customer communication to any of your customers who have purchased the impacted product.
- Quantity
- 33,327 units
- Distribution
- 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
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K152980"]
- PMA numbers
- not on file
- Product code
- DRS
- Firm FEI
- 2015691
- Firm city
- Irvine
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28