Edwards Lifesciences, LLC IntraClude Intra-Aortic Occlusion Device, REF: ICF100, 10.5 Fr (3.5 mm) X 39.4" (100 cm), Rx Only, Sterile EO The IntraClude intra-aortic occlusion device is indicated for use in patients undergoing cardiopulmonary bypass. The IntraClude intra-aortic occlusion device occludes and vents the ascending aorta when the balloon is inflated. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
IntraClude Intra-Aortic Occlusion Device, REF: ICF100, 10.5 Fr (3.5 mm) X 39.4" (100 cm), Rx Only, Sterile EO The IntraClude intra-aortic occlusion device is indicated for use in patients undergoing cardiopulmonary bypass. The IntraClude intra-aortic occlusion device occludes and vents the ascending aorta when the balloon is inflated.
Brand
Edwards Lifesciences, LLC
Lot Codes / Batch Numbers
All lot numbers.
Products Sold
All lot numbers.
Edwards Lifesciences, LLC is recalling IntraClude Intra-Aortic Occlusion Device, REF: ICF100, 10.5 Fr (3.5 mm) X 39.4" (100 cm), Rx Only, S due to Possibility of balloon rupture in intra-aortic occlusion devices. If the balloon bursts during cardiopulmonary bypass, the heart can fill and warm, t. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Possibility of balloon rupture in intra-aortic occlusion devices. 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.
Recommended Action
Per FDA guidance
On 05/14/19, the firm, Edwards, mailed "Urgent Product Recall" notices, via overnight service to its customers. The letter described the product, problem and actions to be taken. The letter informed customers of the recall and instructed them to do the following: 1) Review this field safety notice to understand the potential hazard. 2) Complete and return the attached Acknowledgement Form within five (5) business days of receiving this notice to Customer Service. 3) Complete and return the Product Reconciliation Form to Customer Service; return affected devices with the Return Goods Authorization (RGA) provided. 4) Distribute this notice within your organization or to any organization where the potentially affected devices have been transferred. If you have further distributed this product, notify your customers to the user level. Report any balloon failures to the recalling firm. Customers with additional questions were encouraged to call Customer Service Monday through Friday at (800) 424-3278, Option 1, from 8:00 AM - 4:00 PM Pacific Time. On 07/09/19, Urgent Product Recall notices were mailed via next-day service to customers informing them of the recall expansion.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026