Edwards Lifesciences CardioVations, EndoClamp aortic catheter 100 cm, REF EC1001, Sterile R, individually packaged, Edwards Lifesciences LLC, Irvine, CA 92614. This product is indicated for use in patients undergoing cardiopulmonary bypass. It occludes the ascending aorta, vents the aortic root and allows delivery of cardioplegia solution to arrest the heart. The pressure lumen allows monitoring of the aortic root pressure.
FDA Recall Z-0644-2009 · Posted 2009-01-05
Recalling FirmEdwards Lifesciences Research Medical, Inc.
Recall StatusTerminated
Product CodeDXC
Date Initiated2008-11-26
Date Terminated2011-08-10
Product Quantity1267 units
Reason for Recall
Balloon rupture: Catheter balloon may rupture during cardiopulmonary bypass procedure. For further information, please telephone Edwards Lifesciences Research Medical, Inc. at 801-565-6173.
Firm Action
All consignees were notified by letter on 11/26/2008 and requested to return any unused product to Edwards. The letter was entitled "PRODUCT RECALL." Questions could be referred to the Edwards representative or call 800-424-3278.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Globally - USA including the states of AK, AL, CA, CO, CT, DC, DE, FL, GA, IA, IL, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NV, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI, and WV. VA facilities in VA and WI. No military distribution. Foreign distribution to Australia, Canada, Switzerland and UK.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.