Brand Name: Finesse BTK Multicath Product Name: Injectable… — Class II medical device recall Z-1704-2026
Ongoing recall by SUMMA THERAPEUTICS, LLC, reported 2026-04-08, distributed nationwide. Potential for the balloon in the device to not meet burst specifications.
| Recall number | Z-1704-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SUMMA THERAPEUTICS, LLC, Allston, MA, United States |
| Recall initiated | 2025-07-21 |
| Classified | 2026-03-30 |
| Reported by FDA | 2026-04-08 |
| Distributed | Nationwide (US) |
| Quantity | 22 units |
| UPC / GTIN / UDI-DI | 00810017490967 |
| Lot numbers | 231296, 231296A, 240095, 240095A, 240502 |
| Model numbers | FS252251502 |
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
Reason for recall
Potential for the balloon in the device to not meet burst specifications.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1704-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.