Device recall
Z-1704-2026: Brand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Balloon…
FDA device recall · Class II · SUMMA THERAPEUTICS, LLC
Key facts
| Recall number (Z-number) | Z-1704-2026 |
|---|---|
| Recall event | 98493 |
| Product | Brand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Balloon Catheter Model/Catalog Number: FS252251502 Product Description: 5 French sheath, 0.014" guidewire compatible over-the-wire injectable angioplasty balloon catheter, balloon diameter 2.5mm, balloon length 225mm, catheter… |
| Product code | LIT |
| Recalling firm | SUMMA THERAPEUTICS, LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K230263, K241740 |
| FEI number | 3027395815 |
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