CLASS II ONGOING Device recall · Reported 6 Dec 2023 · FDA Enforcement Report

Acumen IQ Sensor with Vamp System, REFs: AIQS6AZ & AIQS6AZ5 recalled

Edwards Lifesciences is recalling Acumen IQ Sensor with Vamp System, REFs: AIQS6AZ & AIQS6AZ5, Sterileeo, distributed in 43 states. The recall was initiated on 4 Oct 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAIQS6AZ: UDI: 00690103201109/ Lot # 64891675; AIQS6AZ5: UDI: 00690103200980/ Lot # 64858220, 64858220, 64858341, 64918655, 64933575, 64939369, 64964945, 64992113

Quantity recalled6,714 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0410-2024
FDA event ID: 93279
Recalling firm: Edwards Lifesciences, Irvine, CA
Classification: Class II
Status: Ongoing
Recall initiated: 4 Oct 2023
FDA classified: 29 Nov 2023
Reported: 6 Dec 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Heart & Vascular Devices

Timeline

4 Oct 2023	Recall initiated by company
29 Nov 2023	Classified by FDA	+56 days
6 Dec 2023	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Acumen IQ Sensor with VAMP System, REFs: AIQS6AZ & AIQS6AZ5, STERILEEO, Rx only. For use in intravascular pressure monitoring.

Where it was distributed

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

Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Florida Georgia Iowa Illinois Kansas Kentucky Louisiana Massachusetts Maryland Michigan Minnesota Missouri

Questions about this recall

Why was it recalled?

Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.

Which lots are affected?

AIQS6AZ: UDI: 00690103201109/ Lot # 64891675; AIQS6AZ5: UDI: 00690103200980/ Lot # 64858220, 64858220, 64858341, 64918655, 64933575, 64939369, 64964945, 64992113

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

5 other products · FDA event 93279

Reported	Class	Recall	Company	Reason	Where
6 Dec 2023	CLASS II	TruWave Pressure monitoring set recalled by Edwards Lifesciences	Edwards Lifesciences	Other	43 states
6 Dec 2023	CLASS II	FloTrac Sensor recalled by Edwards Lifesciences	Edwards Lifesciences	Device Malfunction	43 states
6 Dec 2023	CLASS II	TruWave with Vamp System Pressure monitoring set recalled	Edwards Lifesciences	Other	43 states
6 Dec 2023	CLASS II	FloTrac Sensor with Vamp System recalled by Edwards Lifesciences	Edwards Lifesciences	Device Malfunction	43 states
6 Dec 2023	CLASS II	Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5 recalled	Edwards Lifesciences	Device Malfunction	43 states

More recalls from Edwards Lifesciences

All 95

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20 May 2026Device	CLASS II	Edwards Evoque tricuspid delivery system recalled	Edwards Lifesciences	Other	Nationwide
16 Jul 2025Device	CLASS I	Optisite Arterial Cannula recalled by Edwards Lifesciences	Edwards Lifesciences	Device Malfunction	Nationwide
16 Jul 2025Device	CLASS I	Fem-flexii Femoral Arterial Cannula recalled by Edwards Lifesciences	Edwards Lifesciences	Device Malfunction	Nationwide
16 Jul 2025Device	CLASS I	Fem-flex II Femoral Arterial Cannula recalled by Edwards Lifesciences	Edwards Lifesciences	Device Malfunction	Nationwide
16 Jul 2025Device	CLASS I	Fem-flex II Femoral Arterial Cannula recalled by Edwards Lifesciences	Edwards Lifesciences	Device Malfunction	Nationwide

Other Heart & Vascular Devices recalls

All 6,199

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16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes: *Bardex¿ I.C recalled	C.R. Bard	Other	Nationwide
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16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide