Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Arrow Bipolar Balloon Electrode Catheter 5 Fr. 105 cm Recalled by Arrow International Inc Due to Marketed without a 510K
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Arrow International Inc directly.
Affected Products
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.
Quantity: 4 units
Why Was This Recalled?
Marketed without a 510K
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Arrow International Inc
Arrow International Inc has 431 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report