Recall Z-1929-2018 ยท DXC Clamp, Vascular
Edwards Lifesciences, LLC
Edwards Lifesciences' IntraClude Intra-Aortic Occlusion Device. Packaged in a sterile barrier system. Model Number: ICF100. Designed to occlude the ascending aorta.
| Date | Mar 30, 2018 |
| Status | Terminated |
| Reason | Possible leak at distal open end of the strain relief, which causes medical staff to continue adding inflation fluid to maintain balloon pressure for adequate occlusion of the ascending aorta. |
| Root cause | Under Investigation by firm |
| Action | Customers were notified on about 03/30/2018 via an Urgent Medical Device Safety Notice. Instructions included to review the field safety notice and understand the potential hazard, review the recall with appropriate clinical staff at their institution, complete and return the acknowledgement form, and distribute the notification within the organization where potentially affected devices may have been transferred. Questions can be directed to Edwards Customer Service, Monday through Friday at 800-424-3278 form 8:00 AM - 4:00 PM Pacific Time. |
| Quantity | 3,052 units total |
| Distribution | Worldwide Distribution -- USA, to the states of AL, AZ, CA, CO, CT, FL, GA, IL, IN, KY, MA, MI, MS, MO, NV, NJ, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, and WV; and, the countries of to Australia, Austria, Belgium, Canada, Colombia, Czech Republic, France, Germany, Israel, Italy, Luxembou |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163693 | IntraClude Intra-Aortic Occlusion Device Edwards Lifesciences, LLC, Jan 26, 2017 |