Intravascular Pressure Sensor Recalled for Flushing Difficulties During Setup
Edwards Lifesciences is recalling Acumen IQ intravascular pressure monitoring sensors (6,714 units) due to potential flushing difficulties during setup of the pressure monitoring kit.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is a functional setup issue without evidence of patient harm, consistent with low-risk precautionary recalls.
Plain-English summary
Edwards Lifesciences is recalling the Acumen IQ Sensor with VAMP System (model references AIQS6AZ and AIQS6AZ5), a prescription-only device used for intravascular pressure monitoring.
The recall was issued due to the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer. Affected lot numbers include 64891675, 64858220, 64858341, 64918655, 64933575, 64939369, 64964945, and 64992113.
Approximately 6,714 units have been distributed across all U.S. states and to multiple countries internationally.
Healthcare providers using these sensors should contact Edwards Lifesciences for recall guidance and instructions on how to proceed.
The recalled product
- Product
- Acumen IQ Sensor with VAMP System, REFs: AIQS6AZ & AIQS6AZ5, STERILEEO, Rx only. For use in intravascular pressure monitoring.
- Manufacturer
- Edwards Lifesciences, LLC
- Hazard
- Affected units
- 6,714
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- AIQS6AZ: UDI: 00690103201109/ Lot # 64891675
- AIQS6AZ5: UDI: 00690103200980/ Lot # 64858220
- 64858220
- 64858341
- 64918655
- 64933575
- 64939369
- 64964945
- 64992113
Distribution
Part of a larger recall action
This product is one of 6 recalled by Edwards Lifesciences, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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