Edwards Lifesciences Recalls Devices After 3 Deaths Reported

Regulatory NewsRegulatory News | 02 July 2019 |  By 

The US Food and Drug Administration (FDA) recently announced a Class I recall of more than 700 Edwards Lifesciences’ IntraClude Intra-Aortic Occlusion Devices after receiving 22 complaints related to balloon rupture or puncture, including three deaths.

The device is used in patients undergoing cardiopulmonary bypass — a technique described by FDA as when “a machine temporarily takes over the function of the heart and lungs during surgery. When the IntraClude balloon is inflated, the device blocks and vents (occludes) the aorta so that the heart is assessed without interference of other organs.”

But due to the risk of balloon rupture, the IntraClude device may cause serious adverse events linked to the increased time the patient is on cardiopulmonary bypass, including neurological damage, embolism, stroke and death, the agency added. The firm initiated the recall in May.

“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 said.

In March 2018, Edwards also conducted a Class 2 recall of certain IntraClude Intra-Aortic Occlusion Devices because of a possible leak, “which causes medical staff to continue adding inflation fluid to maintain balloon pressure for adequate occlusion of the ascending aorta.”

Edwards Lifesciences Recalls the IntraClude Intra-Aortic Occlusion Device Due to Risk of Balloon Rupture


© 2022 Regulatory Affairs Professionals Society.

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