Device recall
Z-1100-2019: Edwards Lifesciences(R) IntraClude(TM) Intra-Aortic Occlusion Device is a 10.5…
FDA device recall · Class II · Edwards Lifesciences, LLC
Key facts
| Recall number (Z-number) | Z-1100-2019 |
|---|---|
| Recall event | 81928 |
| Product | 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… |
| Product code | DXC |
| Recalling firm | Edwards Lifesciences, LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K163693 |
| FEI number | 2015691 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database