FDAClass IIApril 8, 2026

Brand Name: Finesse BTK Multicath Product Name recall

Brand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Balloon Catheter Model/Catalog Number: FS252251502 Product Description: 5…

Why was Brand Name: Finesse BTK Multicath Product Name recalled?

Potential for the balloon in the device to not meet burst specifications.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model/Catalog Number: FS252251502; UDI-DI: 00810017490967; lots: 240502, 240095, 231296, 231296A and 240095A;

Product
Brand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Balloon Catheter Model/Catalog Number: FS252251502 Product Description: 5…
Recalling firm
SUMMA THERAPEUTICS, LLC
Quantity
22 units
Distribution
US Nationwide distribution in the states of New Jersey, Florida.
Recall date
April 8, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls