Device recall
Z-0311-04: Introducer Sheath is indicated for patients requiring introduction of catheters…
FDA device recall · Class III · Heartport Inc
Key facts
| Recall number (Z-number) | Z-0311-04 |
|---|---|
| Recall event | 27410 |
| Product | Introducer Sheath is indicated for patients requiring introduction of catheters. Introducer Sheath for EndoClamp, aortic catheter, 19Fr. IS19 (07042). |
| 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