Edwards Lifesciences recalls Acumen IQ Sensor with VAMP System (REFs AIQS6AZ & AIQS6AZ5) for potential flushing difficulties during pressure monitoring setup. This device is used for intravascular pressure monitoring and requires a prescription.
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
Edwards Lifesciences is recalling Acumen IQ Sensor with VAMP System devices that may cause flushing difficulties when setting up pressure monitoring kits. This could lead to improper pressure readings during medical procedures.
The device may cause flushing difficulties during setup with the pressure transducer, which could lead to improper pressure readings. This might affect the accuracy of intravascular pressure monitoring during medical procedures.
Patients receiving intravascular pressure monitoring treatments who use the recalled Acumen IQ Sensor with VAMP System devices. Healthcare providers administering these devices are most at risk.
Check for product references AIQS6AZ or AIQS6AZ5. The devices have unique identifiers (UDIs) and specific lot numbers listed in the recall notice. These are prescription-only devices for intravascular pressure monitoring.
Verify the product reference (AIQS6AZ or AIQS6AZ5) and lot numbers provided in the recall notice.
The hazard is potential flushing difficulties during setup of the pressure monitoring kit with the pressure transducer, which could lead to improper pressure readings.
Check for product references AIQS6AZ or AIQS6AZ5 with specific lot numbers listed in the recall notice.
No, the recall does not require immediate discontinuation. The hazard is low risk and does not pose a serious injury risk in normal use.
We’ve drafted a message you can send Edwards Lifesciences to request your refund or repair — edit it as you like.
Subject: Recall Z-0410-2024 — Edwards Lifesciences Edwards Lifesciences Hello, I own a Edwards Lifesciences that is covered by recall Z-0410-2024 from Edwards Lifesciences. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
