Allston, MA, United States
SUMMA THERAPEUTICS, LLC recalls
1 recall recorded since 2018, most recently on 21 July 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 21 July 2025
- Reason
- Potential for the balloon in the device to not meet burst specifications.
- Distribution
- US Nationwide distribution in the states of New Jersey, Florida.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1704-2026
- 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 angi
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.