Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Safire Duo Ablation Catheter MediGuide Enabled Recalled by St. Jude Medical Due to St. Jude Medical Cardiovascular and Ablation Technologies Division...
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 St. Jude Medical directly.
Affected Products
Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and A700238, Rx only, Sterile EO. Intended for creating endocardial lesions during cardiac ablation procedures (mapping, stimulation and ablation) for the treatment of typical atrial flutter.
Quantity: 46
Why Was This Recalled?
St. Jude Medical Cardiovascular and Ablation Technologies Division is performing a voluntary notification regarding selected batched of Safire Duo Ablation Catheter MediGuide Enabled. These units have a cable connector configuration that is different than intended.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About St. Jude Medical
St. Jude Medical has 19 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report