FDA DeviceClass IINotable

FDA Recall: Brand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Balloon Catheter Model/Cata

Date: 2026-04-08
Brand: SUMMA THERAPEUTICS, LLC
Category: Medical Device
FDA Class: Class II

Description

Potential for the balloon in the device to not meet burst specifications.

Hazard

Potential for the balloon in the device to not meet burst specifications.

Remedy

22 units

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