# FDA recall Z-0409-2024

> **Edwards Lifesciences, LLC** · Class II · device recall initiated 2023-10-04.

## 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.

## 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

## Key facts

- **Recall number:** Z-0409-2024
- **Recalling firm:** Edwards Lifesciences, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-10-04
- **Report date:** 2023-12-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irvine, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0409-2024

## Citation

> AI Analytics. FDA recall Z-0409-2024. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-0409-2024. Source: US FDA. Licensed CC0.

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