Recall Z-1704-2026 · LIT Catheter, Angioplasty, Peripheral, Transluminal
SUMMA THERAPEUTICS, LLC
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
| Date | Mar 30, 2026 (initiated Jul 21, 2025) |
| Status | Open, Classified |
| Reason | Potential for the balloon in the device to not meet burst specifications. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 22 units |
| Distribution | US Nationwide distribution in the states of New Jersey, Florida. |
| FDA record | Open on fda.gov |