Drug recall
Brand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Balloon Catheter Model/Catalog Number…
FDA recall event 98493 · Class II · SUMMA THERAPEUTICS, LLC
Key facts
| Event ID | 98493 |
|---|---|
| Recall numbers | Z-1704-2026 |
| Recalling firm | SUMMA THERAPEUTICS, LLC |
| Product type | Devices |
| Products | Brand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Balloon Catheter Model/Catalog Number: FS252251502 Product Description: 5 French sheath, 0.014" guidewire compatible… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Potential for the balloon in the device to not meet burst specifications. |
| Initiation date | Jul 21, 2025 |
| Report date | Apr 8, 2026 |
| City | Allston |
| State | MA |
| Country | United States |
| FEI number | 3027395815 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: