Device recall
Z-0310-04: SoftClamp II arterial cannula is intended to deliver oxygenated blood for…
FDA device recall · Class III · Heartport Inc
Key facts
| Recall number (Z-number) | Z-0310-04 |
|---|---|
| Recall event | 27410 |
| Product | SoftClamp II arterial cannula is intended to deliver oxygenated blood for cardiopulmonary bypass during surgery. The product also allows the hemostatic introduction and removal of the Heartport EndoClamp-ST II aortic catheter. SoftClamp II arterial cannula, 24Fr. SCK (06724). Cannulas are also… |
| Product code | DWF |
| Recalling firm | Heartport Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Oct 19, 2005 |
| 510(k) numbers | K955121, K971291, K972570, K974736 |
| FEI number | 3000719637 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 Products in the same recall event
- 100–999 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