Device recall
Z-0811-05: The Heartport EndoClamp aortic catheter is a 10.5 Fr. wirewound, three-lumen…
FDA device recall · Class II · Heartport, Inc.
Key facts
| Recall number (Z-number) | Z-0811-05 |
|---|---|
| Recall event | 31819 |
| Product | The Heartport EndoClamp aortic catheter is a 10.5 Fr. wirewound, three-lumen catheter with an elastomeric balloon near its tip. This device is used with a 200 cm j-hook guide wire accessory device. |
| Product code | DWZ |
| Recalling firm | Heartport, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 31, 2005 |
| 510(k) numbers | K974175 |
| FEI number | 3000719637 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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