FDA-Device2026-04-08Class IIPROCESSING DEFECT
Summa Therapeutics Finesse BTK Multicath balloon catheter recalled for burst specification failure
OTHERNationwide distribution
Stop using Finesse BTK Multicath catheters
Summa Therapeutics is recalling certain Finesse BTK Multicath injectable angioplasty balloon catheters because the balloon may not meet burst strength specifications. This could cause the balloon to rupture unexpectedly during a medical procedure. The recall affects 22 units distributed in New Jersey and Florida.
- If you have a Finesse BTK Multicath catheter (model FS252251502, lots 240502, 240095, 231296, 231296A, or 240095A), stop using it immediately
- Contact your medical facility or Summa Therapeutics for instructions on device replacement or return
- Consult with your healthcare provider if you have already undergone a procedure with this device
Hazard
Potential for the balloon in the device to not meet burst specifications.
Sold states
US Nationwide distribution in the states of New Jersey, Florida.
Affected count
22 units
Manufactured in
119 Braintree St Ste 508, Allston, MA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1704-2026Don't want to check this manually?
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