FDAFDA · Food and drugs·Recall number Z-0187-2014
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.
Published November 20, 2013 · Recall initiated: October 11, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- St. Jude Medical
- Distributor
- Nationwide Distribution including the states of KY, OH, TX, MA, and NC.
- Lot
- Catalog Number A700238, Batch Number 4113243, 4152911. Catalog Number A700240, Batch Number 4113242, 4124985.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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