Acumen IQ Sensor with VAMP System — Class II medical device recall Z-0410-2024

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-0410-2024`
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	6,714 units
UPC / GTIN / UDI-DI	`00690103200980`, `00690103201109`
Lot numbers	`64858220`, `64858341`, `64891675`, `64918655`, `64933575`, `64939369`, `64964945`, `64992113`, `AIQS6AZ5`
Model numbers	`AIQS6AZ`, `AIQS6AZ5`

Product

Acumen IQ Sensor with VAMP System, REFs: AIQS6AZ & AIQS6AZ5, STERILEEO, Rx only. 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-0410-2024. 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.