Edwards Lifesciences Issues Recall of Its IntraClude Intra-Aortic Occlusion Device Used in Cardiopulmonary Bypass Procedures
UNITED STATES – According to an FDA safety notification available at www.accessdata.fda.gov and an online article published by www.massdevice.com, Edwards Lifesciences has issued a recall of its IntraClude Intra-Aortic Device used in cardiopulmonary bypass amid concerns that the device’s balloon could burst during a procedure.
Edwards Lifesciences, a medical device manufacturer, has issued a field safety notice recalling its IntraClude Intra-Aortic Occlusion Device used by surgeons in cardiopulmonary bypass procedures, stating that there is a high-risk that the device’s balloon could burst. If the balloon does burst during a procedure, a patient’s heart could fill and warm, obscuring the operative site.
The United States Food and Drug Administration (FDA) has designated the IntraClude recall as Class I, which means that failure of the device may lead to serious patient injuries or death. A Class I recall is the most serious type of recall issued by the FDA. While no injuries or deaths have been reported, the risk of balloon bursting is substantial enough that Edwards Lifesciences believes it is essential to pull the affected product from the market and address the defects and safety concerns.
Edwards Lifesciences recommends that medical professionals should either exchange the IntraClude device or adjust their operating strategies, such as external cross-clamp placement, conversion to open procedure, or performing the procedure under fibrillation.
Specific information about the IntraClude recall, as reported by the FDA, includes the following:
- Device Name – IntraClude Intra-Aortic Occlusion Device;
- Lot Numbers
- 61723505; and
- Number of Devices Subject to the Recall – 757
- Date Edwards Lifesciences Initiated the Recall – May 14, 2019
- Date Range of Reported Complaints – January 2019 to April 2019
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