Z-0187-2014 Class II Terminated
FDA device recall Z-0187-2014 was initiated by St. Jude Medical on Oct 11, 2013 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Jun 9, 2014). Affected quantity: 46.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 20, 2013
- Initiation Date
- Oct 11, 2013
- Termination Date
- Jun 9, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 46
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Nationwide Distribution including the states of KY, OH, TX, MA, and NC.
Code Information
Catalog Number A700238, Batch Number 4113243, 4152911. Catalog Number A700240, Batch Number 4113242, 4124985.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0187-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026