Class II — SUMMA THERAPEUTICS, LLC
| Recalling firm | Summa Therapeutics, LLC |
|---|---|
| Registered facility | SUMMA THERAPEUTICS, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Potential for the balloon in the device to not meet burst specifications. |
| 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 working length 150cm Component: NA |
| Quantity | 22 units |
| Distribution | US Nationwide distribution in the states of New Jersey, Florida. |
| Initiated | 2025-07-21 |
| Classified | 2026-03-30 |
| Recall number | Z-1704-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — SUMMA THERAPEUTICS, LLC (Z-1704-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98493/
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