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FDA designates recall of intra-aortic occlusion device as class 1

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The FDA has designated Edwards Lifesciences’ product recall of an intra-aortic occlusion device as a class 1 recall, the most serious kind. The recall affects 757 devices distributed between May 1, 2017, and Feb. 19, 2019.

The risk for balloon rupture with the device (IntraClude intra-aortic occlusion device), which is used in patients undergoing cardiopulmonary bypass, may prolong the procedure time and compromise the safety of the patient, according to a MedWatch report from the FDA. Serious adverse health consequences may result from the balloon bursting including embolism, neurological damage, death and stroke.

There have been 22 complaints and three deaths related to balloon puncture or rupture, according to the report.

Edwards Lifesciences distributed an urgent recall notification to customers on May 14 alerting them to review the field safety notice about the potential hazard, complete and return an acknowledgement form and complete and return a product reconciliation form for affected devices, according to the report.