Recall Z-1100-2019 ยท DXC Clamp, Vascular
Edwards Lifesciences, LLC
Edwards Lifesciences(R) IntraClude(TM) Intra-Aortic Occlusion Device is a 10.5 Fr (3.5mm), triple lumen, 100cm long catheter with an elastomeric balloon near its distal tip designed to occlude the ascending aorta in order to partition the aortic root from arterial circulation. The balloon expands to occlude a range of aorta sizes from 20 to 40 mm. The large central lumen of the IntraClude De
| Date | Jan 16, 2019 |
| Status | Open, Classified |
| Reason | Edwards Lifesciences has received a limited number of customer reports regarding an inter-lumen leak between the cardioplegia lumen and pressure lumen in the device. |
| Root cause | Process control |
| Action | The firm Edwards Lifesciences, disseminated the notices on 01/16/2019 by letter entitled "URGENT PRODUCT NOTIFICATION ACTION REQUIRED". The letter stated the problem, how to identify it, and actions to be taken. The customers were instructed to do the following: 1. Review this field safety notice to understand the potential hazard. 2. Meet and review with appropriate clinical staff at your institution. 3. Complete and return the acknowledgement form attached to this letter via fax to Fax: 949.250.2525 or email to www.edwards.com within five (5) business days of receiving this notice. 4. Dis |
| Quantity | 2715 units |
| Distribution | Worldwide Distribution: US (nationwide) and countries of: Australia, Austria, Belgium, Canada, Czech Republic, France Germany, Israel, Italy, Luxembourg, Netherlands, Poland, Romania, Spain, Sweden, Switzerland, UAE, and United Kingdom. |
| 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 |