Edwards Lifesciences recalls IntraClude Intra-Aortic Occlusion Devices with possible leak at distal open end causing medical staff to add inflation fluid. Affected units include specific model numbers and lot numbers.
Possible leak at distal open end of the strain relief, which causes medical staff to continue adding inflation fluid to maintain balloon pressure for adequate occlusion of the ascending aorta.
Edwards Lifesciences is recalling IntraClude Intra-Aortic Occlusion Devices due to a possible leak at the distal open end. This leak could cause medical staff to continue adding inflation fluid to maintain balloon pressure, which may lead to complications during use.
The device has a potential leak at the distal open end. This leak causes medical staff to add inflation fluid to maintain balloon pressure for adequate occlusion of the ascending aorta, which could lead to complications if not properly managed.
Medical professionals using the IntraClude device for aortic occlusion procedures are most at risk. Patients receiving this device are also affected but the hazard is specific to medical staff handling the device.
Check for model number ICF100 and lot numbers listed in the recall notice. The device is packaged in a sterile barrier system and used for aortic occlusion procedures.
Verify the model number (ICF100) and lot numbers listed in the recall notice.
The device has a possible leak at the distal open end, which causes medical staff to continue adding inflation fluid to maintain balloon pressure for adequate occlusion of the ascending aorta.
Check for model number ICF100 and lot numbers listed in the recall notice, including specific numbers like 60876468, 60850885, and others.
The recall does not specify a remedy, so contact Edwards Lifesciences for further instructions.
We’ve drafted a message you can send Edwards Lifesciences to request your refund or repair — edit it as you like.
Subject: Recall Z-1929-2018 — Edwards Lifesciences Edwards Lifesciences Hello, I own a Edwards Lifesciences that is covered by recall Z-1929-2018 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.
