Reported Apr 8, 2026 · Ongoing
Brand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Balloon Catheter Model/Catalog Number:…
Summa Therapeutics, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SUMMA THERAPEUTICS, LLC · 119 Braintree St Ste 508 · Allston, MA · 02134-1851
Is this the product you have?
- Brand NameFinesse
- BTK Multicath Product NameInjectable Angioplasty
- Balloon Catheter Model/Catalog NumberFS252251502
- Product Description5 French sheath, 0.014" guidewire compatible over-the-wire injectable angioplasty balloon catheter, balloon diameter 2.5mm, balloon length 225mm
- catheter working length 150cm ComponentNA
- Lot codes and dates
- Model/Catalog NumberFS252251502
- UDI-DI00810017490967
- lots
240502240095231296231296A and 240095A
- Amount recalled
- 22 units
Where it was sold
Why it was recalled
Potential for the balloon in the device to not meet burst specifications.
This product could cause temporary or reversible health problems — stop using it.
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