Edwards Lifesciences recalls a limited number of IntraClude intra-aortic occlusion devices due to potential inter-lumen leaks between cardioplegia and pressure lumens, which could affect medical procedures.
Edwards Lifesciences has received a limited number of customer reports regarding an inter-lumen leak between the cardioplegia lumen and pressure lumen in the device.
Edwards Lifesciences is recalling a limited number of IntraClude intra-aortic occlusion devices because some have reported leaks between the cardioplegia and pressure lumens. This could lead to complications during medical procedures if the device fails to properly isolate the aorta.
The device has three lumens: one for cardioplegia delivery, one for pressure monitoring, and one for balloon inflation. A leak between the cardioplegia and pressure lumens could cause improper blood flow monitoring or fluid management during surgery.
Patients who have received the recalled IntraClude device during cardiac surgery are most at risk. Healthcare providers using the device for aortic root isolation may also be affected.
The recalled device is a 10.5 Fr (3.5mm), triple lumen, 100cm long catheter with an elastomeric balloon. It was used in cardiac surgeries to occlude the aorta. Specific serial numbers are listed in the recall notice.
Look for the serial numbers listed in the recall notice (e.g., 60850886, 60850888, etc.) on the device packaging or label.
The recall reports a limited number of inter-lumen leaks, but the device is generally safe. Most users do not experience issues.
Check the serial numbers listed in the recall notice (e.g., 60850886, 60850888, etc.) on the device or its packaging.
No, the recall does not require immediate discontinuation. Patients and providers should check the serial numbers to determine if their device is affected.
We’ve drafted a message you can send Edwards Lifesciences to request your refund or repair — edit it as you like.
Subject: Recall Z-1100-2019 — Edwards Lifesciences Edwards Lifesciences Hello, I own a Edwards Lifesciences that is covered by recall Z-1100-2019 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.
