CardioVations Ethicon, a Johnson and Johnson company, EndoClamp aortic catheter 100 cm, REF EC1001, Sterile R, individually packaged, Heartport, Inc., Somerville, NJ 08876. 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
This recall has been terminated (originally issued January 5, 2009).
- Recall Initiated
- November 26, 2008
- Posted
- January 5, 2009
- Terminated
- August 10, 2011
- Recall Number
- Z-0645-2009
- Quantity
- 963 units
- Firm Location
- West Midvale, UT
- Official Source
- View on FDA website ↗
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.
Distribution
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.
Lot / Code Info
Lot numbers: MS0208019, MS0208020, MS0208027, MS0208035, MS0208036, MS0408002, MS0408008, MS1007022, MS1007026, MS1207032, MS1207033, MS1207042, MS1207043, and MS1207044.
Root Cause
Nonconforming Material/Component
Action Taken
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.