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Recall of IntraClude Device Used In Patients Undergoing Cardiopulmonary Bypass

By Burg Simpson

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July 2, 2019   Ohio Dangerous Drugs and Medical Devices

By Melanie S. Bailey, Burg Simpson Shareholder

Recall of IntraClude Device Used In Patients Undergoing Cardiopulmonary Bypass

Edwards Lifesciences has issued a Class I recall of its IntraClude Intra-Aortic Occlusion Device used in patients undergoing cardiopulmonary bypass.  Cardiopulmonary bypass machines are used to temporarily take over the function of the heart and lungs during surgery.  The IntraClude device includes a balloon which is inflated to block the aorta so the heart is assessed without interference of other organs.  The device is being recalled due to a risk of balloon rupture during use, which may add time to the procedure and compromise the safety of patients.  The recall only includes certain IntraClude device lots distributed between May 1, 2017 and February 19, 2019.

If you or a loved one suffered complications during surgery involving a cardiopulmonary bypass machine, please contact one of the experienced medical device attorneys at Burg Simpson today.  Our award-winning lawyers would be happy to discuss your potential claim.  Call 1-800-713-9340 or fill out our contact form for a free no obligation consultation today.

About Shareholder Melanie Bailey:

Melanie S. Bailey earned a Bachelor of Arts Degree from Northern Kentucky University, cum laude, and a Juris Doctorate Degree from Salmon P. Chase College of Law, cum laude.

Prior to joining Burg Simpson Eldredge Hersh & Jardine, P.C., Melanie worked for law firms in Kentucky and Ohio, practicing in the areas of complex civil litigation and class action litigation.  In 2006, she was court appointed Class Counsel in a class action employment case on behalf of Wal-Mart employees in the state of Kentucky.  Melanie is a member of the firm’s Cincinnati office and practices in the areas of complex civil litigation, pharmaceutical and general products liability, multi-district litigation, personal injury, wrongful death, and class action litigation. During her tenure at Burg Simpson, Melanie has devoted time to working on pharmaceutical cases, such as Ortho Evra, contaminated Heparin, Yasmin/Yaz, and Depakote.  She has also litigated several product liability cases for defective medical devices, such as hip replacements and knee replacements.

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