Arrow Bipolar Balloon Electrode Catheter Recalled for Marketing Without FDA 510K Clearance
Arrow International is recalling 4 units of an electrode catheter marketed without FDA 510(k) clearance. The device was intended for electrophysiology studies.
- Product
- Arrow Bipolar Balloon Electrode Catheter 5 Fr. 105 cm, Product Code: AI-07154 - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.
- Category
- Medical Device
- Distribution
- Distributed nationwide