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Risk of Balloon Rupture Prompts Edwards' IntraClude Recall

FDA said it has received 22 complaints related to balloon rupture or punctures with this device and three deaths have been reported.

A total of 24 medical devices have been recalled from the U.S. market so far in 2019 compared to 14 recalls this time last year.

MD+DI/Amanda Pedersen

Edwards Lifesciences is recalling its IntraClude intra-aortic occlusion device due to the risk of balloon rupture. FDA said it has received 22 complaints of balloon rupture or punctures with the device and three deaths have been reported.

The IntraClude device is used in patients undergoing cardiopulmonary bypass - a technique in which 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.

FDA said IntraClude balloon bursting may cause serious adverse health consequences related to increased time the patient is on cardiopulmonary bypass, including neurological damage, embolism, stroke, and death.

The U.S. recall includes 757 devices that were distributed between May 1, 2017 and February 19, 2019

Customer instructions for returning affected devices can be found here.

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