Edwards Lifesciences recalls Acumen IQ Sensors with specific model numbers and lots due to potential flushing difficulties during pressure monitoring setup. Affected users should contact for remedy details.
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
Edwards Lifesciences is recalling Acumen IQ Sensors with model numbers AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, and AIQS8R5. The recall is due to a potential risk of flushing difficulties when setting up the pressure monitoring kit with a pressure transducer.
The device may cause flushing difficulties during setup with a pressure transducer, which could lead to improper pressure monitoring. This is a potential issue during the initial setup process but does not indicate a high risk of serious injury.
Healthcare professionals using the Acumen IQ Sensor for intravascular pressure monitoring are most likely affected. Patients using this device under medical supervision are at minimal risk.
Check for model numbers AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, or AIQS8R5 on the device. The lot numbers listed in the recall notice are also specific identifiers for affected units.
Identify the model number on the Acumen IQ Sensor to see if it matches AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, or AIQS8R5.
The recall is due to potential flushing difficulties during setup of the pressure monitoring kit with a pressure transducer.
The recall does not specify a remedy, so contact Edwards Lifesciences for further instructions.
Yes, the recall lists specific lot numbers for each model, such as 64858340 for AIQS6.
We’ve drafted a message you can send Edwards Lifesciences to request your refund or repair — edit it as you like.
Subject: Recall Z-0409-2024 — Edwards Lifesciences Edwards Lifesciences Hello, I own a Edwards Lifesciences that is covered by recall Z-0409-2024 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.
