[pending] Brand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Balloon Catheter Model/Cata
Pending LLM rewrite. Source: FDA_DEVICE Z-1704-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Potential for the balloon in the device to not meet burst specifications.
The recalled product
- 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 le
- Manufacturer
- SUMMA THERAPEUTICS, LLC
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Model/Catalog Number: FS252251502
- UDI-DI: 00810017490967
- lots: 240502
- 240095
- 231296
- 231296A and 240095A
Distribution
Distributed nationwide across the United States.
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