Recalling firm
SUMMA THERAPEUTICS, LLC
Product type
Device
Status
Ongoing
Report date
2026-04-08
Distribution
US Nationwide distribution in the states of New Jersey, Florida.
Firm state
MA
Product quantity
22 units
Initiated by
Voluntary: Firm initiated
Reason for recall
Potential for the balloon in the device to not meet burst specifications.
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
Code / lot info
Model/Catalog Number: FS252251502; UDI-DI: 00810017490967; lots: 240502, 240095, 231296, 231296A and 240095A;
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.