Device product
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.
Z-0187-2014
Product summary
- Firm
- St. Jude Medical
- Event
- Event 66574
- Status
- Terminated
- Classification
- Class II
- Quantity
- 46
- Official record key
device-enforcement:Z-0187-2014
Official wording
Reason: 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.
Code information: Catalog Number A700238, Batch Number 4113243, 4152911. Catalog Number A700240, Batch Number 4113242, 4124985.
Distribution pattern: Nationwide Distribution including the states of KY, OH, TX, MA, and NC.
Derived failure modes
-
Unknown
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.