Recall Z-1704-2026— SUMMA THERAPEUTICS, LLC
Class II · Ongoing
Class II FDA medical device recall by SUMMA THERAPEUTICS, LLC, initiated 2025-07-21. It names 2 FDA 510(k) clearances: K241740, K230263. 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 length 225mm, catheter working length 150cm Component: NA. Reason: Potential for the balloon in the device to not meet burst specifications..
- Recalling firm
- SUMMA THERAPEUTICS, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-07-21
- Firm location
- Allston, MA, United States
510(k) clearances named in this recall
2 on FDA's record- K241740 — Finesse Injectable PTA Balloon Dilatation Catheter
- K230263 — Finesse Injectable PTA Balloon Dilatation Catheter
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
Reason for recall
Potential for the balloon in the device to not meet burst specifications.
Data sourced from openFDA. This site is unofficial and independent of the FDA.