FDA DevicesClass II
Brand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Balloon ...
Published: April 8, 2026Recall ID: Z-1704-2026Category: devicesCountry: US
Reason for Recall / Hazard
Potential for the balloon in the device to not meet burst specifications.
Product Description & Identification
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 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
Additional Source Details
| Field | Value |
|---|---|
| City | Allston |
| State | MA |
| Event id | 98493 |
| Address 1 | 119 Braintree St Ste 508 |
| Code info | Model/Catalog Number: FS252251502; UDI-DI: 00810017490967; lots: 240502, 240095, 231296, 231296A and 240095A; |
| Postal code | 02134-1851 |
| Report date | 20260408 |
| Product type | Devices |
| Product quantity | 22 units |
| Reason for recall | Potential for the balloon in the device to not meet burst specifications. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20250721 |
| Initial firm notification | Letter |
| Center classification date | 20260330 |
Overview
- Recalling FirmSUMMA THERAPEUTICS, LLC
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution in the states of New Jersey, Florida.