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Acumen IQ

Edwards Lifesciences LLC · Model AIQS6R · UDI-DI 00690103201093

DRS Prescription

510(k) clearances

3,904

Adverse events (25 deaths)

236

Recalls

Facilities

Description

ACUMEN IQ SENSOR 60" / 152CM with Red Cap

Recalls

Date	Firm	Reason
2026-03-24	Medline Industries, LP	Medline has identified the presence of particulate within the fluid path of the Manifolds.
2026-03-24	Medline Industries, LP	Medline has identified the presence of particulate within the fluid path of the Manifolds.
2025-02-12	MEDLINE INDUSTRIES, LP - Northfield	The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.
2023-11-10	Smiths Medical Asd Inc	There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inad
2023-11-10	Smiths Medical Asd Inc	There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inad
2023-11-10	Smiths Medical Asd Inc	There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inad
2023-11-10	Smiths Medical Asd Inc	There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inad
2023-11-10	Smiths Medical Asd Inc	There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inad
2023-11-10	Smiths Medical Asd Inc	There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inad
2023-11-10	Smiths Medical Asd Inc	There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inad

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.