Recall Z-0187-2014— St. Jude Medical
Class II · Terminated
Class II FDA medical device recall by St. Jude Medical, initiated 2013-10-11, terminated 2014-06-09. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- St. Jude Medical
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-10-11
- Terminated
- 2014-06-09
- Firm location
- Plymouth, MN, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.