Edwards Lifesciences (NYSE:EW) issued a field safety notice warning users that its IntraClude balloon could burst during cardiopulmonary bypass.

The high-risk balloon burst could cause injury, according to the company. When the balloon bursts, the heart can fill and warm and obscure the operative site.

Edwards Lifesciences says the device needs to be exchanged or operate strategy would need to be changed, including an external cross-clamp placement, conversion to open procedure or performing the procedure under fibrillation.

The IntraClude Intra-Aortic Occlusion Device is a triple-lumen catheter that features an elastomeric balloon near the distal tip. It is designed to occlude the ascending aorta to partition the aortic root from arterial circulation. The balloon can expand to occlude a range of aorta sizes from 20 to 40 mm and can be used in the femoral approach with the Edwards EndoReturn arterial cannula or Edwards Introducer Sheath.

Edwards received complaints about the device related to balloon rapture/puncture and reported an increase in complaints between January and April 2019.