FDA recall, , Moderate risk
Summa Therapeutics Finesse BTK Multicath Injectable Angioplasty Balloon Catheter
The injectable angioplasty balloon catheter may not meet burst specifications.
Summary by Recall Canary from the FDA notice
What happened
SUMMA THERAPEUTICS, LLC of Allston, Massachusetts is recalling the Finesse BTK Multicath Injectable Angioplasty Balloon Catheter because the balloon in the device may not meet burst specifications. The recall affects 22 units distributed in Florida and New Jersey.
The product is a 5 French sheath, 0.014" guidewire compatible over-the-wire injectable angioplasty balloon catheter with a balloon diameter of 2.5mm, balloon length of 225mm, and catheter working length of 150cm. The recall began on July 21, 2025, and was added to the FDA's Enforcement Report on March 30, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the list below, then check the codes the FDA notice also names.
Injectable Angioplasty Balloon Catheter
- Model number
- FS252251502
- Lot code
- 240502
- 240095
- 231296
- 231296A
- 240095A
From the FDA notice
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
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of New Jersey, Florida.
- Company
- SUMMA THERAPEUTICS, LLCAllston, Massachusetts
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98493
- Recall number
- Z-1704-2026
- Quantity recalled
- 22 units
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
