Recall Z-1758-2015 ยท DXC Clamp, Vascular
Edwards Lifesciences, LLC
Edwards Lifesciences IntraClude Intra-Aortic Occlusion Device, model number ICF100, 10.5 Fr (3.5 mm) x 39.4" (100 cm) ThruPort System. Packaged sterile and non-pyrogenic in a sealed, peel-type pouch For use in patients undergoing cardiopulmonary bypass.
| Date | Jun 11, 2015 (initiated May 5, 2015) |
| Status | Terminated |
| Reason | Potential device damage on the strain relief near the hub area, which may result in blood leakage. |
| Root cause | Device Design |
| Action | Urgent Medical Device Safety Notice letters were sent via Fed-Ex by May 05, 2015. As part of the customer instructions in the safety notice, customers were requested to review the notice to understand the potential hazard, complete and return the acknowledgement form, and forward copies of the Safety Notice to any organization where the potentially affected devices have been transferred. The device will only be distributed to customers who have returned the acknowledgement form. Questions should be directed to Edwards Customer Service at 800-424-3278. |
| Quantity | 3,360 units. |
| Distribution | Nationwide Distribution -- US, including the states of Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylva |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132175 | EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER Edwards Lifesciences, LLC, Sep 13, 2013 |