FDA Announces Class I IntraClude Device Recall Following Balloon Ruptures, Deaths

Published on July 2, 2019 by Sandy Liebhard

The U.S. Food & Drug Administration (FDA) has announced a Class I recall for Edwards Lifesciences Corp’s IntraClude Intra-Aortic Occlusion device.

The IntraClude device recall follows nearly two-dozen reports of balloon ruptures, including three incidents in which patients died.

What is the IntraClude Device?

Edward Lifesciences’ IntraClude Intra-Aortic Occlusion device is a triple-lumen catheter indicated for use during cardiopulmonary bypass, a surgical technique in which a machine temporarily takes over the function of the heart and lungs.

The IntraClude catheter features an elastomeric balloon near the distal tip. When the balloon inflates, the device blocks and vents the aorta, allowing surgeons to access the patient’s heart without interference from other organs.

IntraClude Device Recall: What’s the Problem?

Edwards Lifesciences issued an Urgent Field Safety Notice for the IntraClude device on May 14th, after balloon rupture complaints increased between January and April.

Yesterday, the FDA confirmed 22 balloon rupture reports, including three patient deaths. Experienced surgeons accustomed to using the IntraClude device were among those making the reports.

An IntraClude balloon rupture can cause the heart to warm, fill, and obscure the operative site. This may result in longer bypass procedures and related health consequences, including neurological damage, embolism, stroke, and death.

“The FDA has identified this as a Class I recall, the most serious type of recall,” the agency said. “Use of these devices may cause serious injuries or death.”

Over 750 Devices Affected by IntraClude Recall

The recall affects 757 IntraClude Intra-Aortic Occlusion Devices (Model: ICF100, UDI code (01) 00690103190007) with the following Lot Numbers: 60972890, 61078031, 61097633, 61139239, 61259627, 61259628, 61713218, 61723505, and 61898939.

Customers with recalled IntraClude devices have been asked to return the products to Edwards Lifesciences.  Questions regarding the IntraClude  recall should be directed to the company at (800) 424-3278, Option 1, Monday through Friday from 8:00 a.m. – 4:00 p.m., PST.

Health care professionals and consumers may report quality problems, injuries, balloon ruptures, and other adverse events associated with the IntraClude Intra-Aortic Occlusion device to the MedWatch: The FDA Safety Information and Adverse Event Reporting Program.