Brand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Balloon Catheter Model/Catalog Number: FS252251
Summary
The FDA issued a Class II for Brand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Balloon by SUMMA THERAPEUTICS, LLC. Reason: Potential for the balloon in the device to not meet burst specifications..
Details
Source
Device Recall
External ID
Z-1704-2026
Action Date
2026-04-08
Status
Ongoing
Category
device
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
Lot/Code Info: Model/Catalog Number: FS252251502; UDI-DI: 00810017490967; lots: 240502, 240095, 231296, 231296A and 240095A;
Quantity Affected: 22 units
Reason for Recall
Potential for the balloon in the device to not meet burst specifications.
Distribution
US Nationwide distribution in the states of New Jersey, Florida.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-07-21
Company
Allston, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 252 device recalls issued in the same week, part of 403 device-related FDA actions this month.
SUMMA THERAPEUTICS, LLC has 2 FDA actions in our database, including 1 recall and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (SUMMA THERAPEUTICS, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SUMMA THERAPEUTICS, LLC have FDA actions?
SUMMA THERAPEUTICS, LLC has 2 FDA actions in our database, including 1 recall and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1704-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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