Edwards Lifesciences recalls IntraClude intra-aortic occlusion devices due to potential balloon rupture during cardiopulmonary bypass, risking heart complications and requiring surgical changes.
Possibility of balloon rupture in intra-aortic occlusion devices. If the balloon bursts during cardiopulmonary bypass, the heart can fill and warm, the operative site may be obscured, and the device will need to be exchanged or operative strategy would need to change, including placement of an external cross-clamp, conversion to an open procedure, or performing the procedure under fibrillation.
Edwards Lifesciences is recalling IntraClude intra-aortic occlusion devices that could rupture during surgery, potentially causing heart complications and requiring surgical changes. This recall affects medical devices used in specific heart surgeries.
If the balloon bursts during cardiopulmonary bypass, the heart can fill and warm, the operative site may be obscured, and the device may need to be exchanged or the surgery altered significantly.
Patients undergoing heart surgery with this device are affected. Surgeons and medical teams using the device are most at risk during procedures.
The device is labeled as IntraClude Intra-Aortic Occlusion Device, REF: ICF100, 10.5 Fr (3.5 mm) X 39.4" (100 cm), Rx Only, Sterile EO. It was sold for prescription use in heart surgeries.
Look for the product name, reference number ICF100, and size 10.5 Fr (3.5 mm) X 39.4" (100 cm) on the device packaging or label.
The recall is due to a possibility of balloon rupture during cardiopulmonary bypass, which could cause heart complications and require surgical changes.
The official recall record does not specify a fix or remedy for this device.
The official recall record does not specify who to contact for help.
We’ve drafted a message you can send Edwards Lifesciences to request your refund or repair — edit it as you like.
Subject: Recall Z-1705-2019 — Edwards Lifesciences Edwards Lifesciences Hello, I own a Edwards Lifesciences that is covered by recall Z-1705-2019 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.
