Summa Therapeutics recalled 22 units of the Finesse BTK Multicath Injectable Angioplasty Balloon Catheter sold to healthcare facilities in New Jersey and Florida. The balloon may not meet burst specifications, raising risk during angioplasty. Healthcare providers must stop using the device immediately and follow recall instructions from Summa Therapeutics.
Potential for the balloon in the device to not meet burst specifications.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact SUMMA THERAPEUTICS, LLC or your healthcare provider for instructions. Notification method: Letter
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Model/Catalog Number: FS252251502; UDI-DI: 00810017490967; Lots: 240502, 240095, 231296, 231296A, 240095A. Sold to facilities in New Jersey and Florida. Sold date: Unknown. Price: Unknown. Quantity: 22 units. Recall date: 2025-07-21. Status: ACTIVE. Distributor: Summa Therapeutics.
The device’s balloon could fail to meet burst specifications. If this occurs during a procedure, it could cause vessel injury or other complications requiring additional intervention.
No injuries or incidents have been reported.
1) Stop using the product. 2) Contact Summa Therapeutics or your healthcare provider for instructions. 3) Follow recall instructions provided in the recall letter. 4) If you are a healthcare provider, isolate affected devices and coordinate with Summa Therapeutics on the remedy. 5) Refund/replacement details are provided in the recall letter.
Recall letter will provide contact instructions. The recall notice here does not include a publicly listed phone number or website.
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