Brand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Balloon Catheter Model/Catalog Number: FS25225150
FDA device recall Z-1704-2026 · posted 2026-03-30 · Open, Classified
Recall details
- Recalling firm
- SUMMA THERAPEUTICS, LLC
- Reason for recall
- Potential for the balloon in the device to not meet burst specifications.
- Action taken
- On July 21, 2025, customers were notified via E-mail. We discovered that the burst test values recorded did not meet the specification of the safety rated burst test average of 17atm. Please review your inventory and we ask that these catheters be returned for further investigation.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- LIT
- Quantity affected
- 22 units
- Distribution
- US Nationwide distribution in the states of New Jersey, Florida.
- Date initiated
- 2025-07-21
- Date posted
- 2026-03-30
- Location
- Allston, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Finesse Injectable™ PTA Balloon Dilatation Catheter (K241740) | Summa Therapeutics | 2024-07-16 |
| Finesse™ Injectable PTA Balloon Dilatation Catheter (K230263) | Summa Therapeutics, LLC | 2023-05-26 |