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
- Recall Number
- Z-1704-2026
- Event Number
- 98493
- Firm
- SUMMA THERAPEUTICS, LLC
- FEI Number
- 3027395815
- Product Code
- LIT
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- July 21, 2025
- Posted
- March 30, 2026
- Address
- 119 Braintree St, Ste 508, Allston, MA, 02134-1851
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
Potential for the balloon in the device to not meet burst specifications.
On July 21, 2025, customers were notified via E-mail. We discovered that the burst test values recorded did not meet the specification of the safety rated burst test average of 17atm. Please review your inventory and we ask that these catheters be returned for further investigation.
US Nationwide distribution in the states of New Jersey, Florida.
22 units