Acumen IQ Sensor — Class II medical device recall Z-0409-2024
Ongoing recall by Edwards Lifesciences, LLC, reported 2023-12-06, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure tra
| Recall number | Z-0409-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edwards Lifesciences, LLC, Irvine, CA, United States |
| Recall initiated | 2023-10-04 |
| Classified | 2023-11-29 |
| Reported by FDA | 2023-12-06 |
| Distributed | 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 |
| Countries outside the US | AE, AR, AT, AU, BE, BH, BR, CA, CH, CL, CO, CR, CZ, DE, DK, EC, ES, FR, GB, GR, GT, HK, ID, IE, IL, IT, JP, KR, MY, NL, NO, NZ, PA, PL, PT, SA, SE, SG, SI, SK, VN |
| Quantity | 33,327 units |
| UPC / GTIN / UDI-DI | 00690103200935, 00690103200942, 00690103200959, 00690103201079, 00690103201086, 00690103201093, 00690103201178 |
| Lot numbers | 64817843, 64835570, 64858050, 64858150, 64858340, 64858645, 64858715, 64858716, 64858717, 64891410, 64891667, 64892324, 64892325, 64892326, 64892327, 64904497, 64904498, 64918260, 64918261, 64918262, 64918263, 64918264, 64918646, 64918647, 64918648, 64918649, 64918650, 64918651, 64918652, 64933520, 64939370, 64988038, 64988040, 65027617, 65067612, 65179001, AIQS65, AIQS6R, AIQS6R5, AIQS8 and 2 more |
| Model numbers | AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R5 |
Product
Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R5, Rx only, Sterile EO. For use in intravascular pressure monitoring.
Reason for recall
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0409-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.