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
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | July 21, 2025 |
| Reported | April 08, 2026 |
| Recalling firm | SUMMA THERAPEUTICS, LLC |
| Country / region | United States MA |
Hazard
Potential for the balloon in the device to not meet burst specifications.
Product description
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
Affected products
- Brand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Balloon Catheter Model/Catalog Number: FS252251502 Product Description: 5 French sheat
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