Device recall
Z-3247-2018: The Shockwave S4 IVL Catheters are intended for lithotripsy-enhanced balloon…
FDA device recall · Class II · Shockwave Medical, Inc.
Key facts
| Recall number (Z-number) | Z-3247-2018 |
|---|---|
| Recall event | 80865 |
| Product | The Shockwave S4 IVL Catheters are intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. Shockwave S4, Peripheral Intravascular… |
| Product code | PPN |
| Recalling firm | Shockwave Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 22, 2020 |
| 510(k) numbers | K180454 |
| FEI number | 3015053858 |
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