Recall Z-0174-2014— St. Jude Medical

Class II FDA medical device recall by St. Jude Medical, initiated 2013-10-11, terminated 2016-03-10. FDA's recall record names no specific 510(k) clearance for this event. Product: US Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and Cool Path Duo Ablation Catheter, MediGuide Enabled REF A700244, Rx only, Sterile EO. The catheters are intended for use with a compatible external irrigation pump and the IBI-15500T9-CP RF Generator at a maximum of 50 Watts. MediGuide Enabled Ablation catheters are used with the MediGuide Technology to enable real-time tip positioning and navigation and in conjunction the the EnSite Velocity System. The MediGuide Technology is indicated for use as an adjunct to fluoroscopy.. Reason: St. Jude Medical Cardiovascular and Ablation Technologies Division is performing a voluntary notification regarding selected batches of Coolpath Duo Ablation Catheter MediGuide Enabled products and Safire Duo Ablation Catheter MediGuide Enabled. These units were inadvertently shipped with the incorrect version of the Instructions for Use (IFU)..

Recalling firm

St. Jude Medical

Classification

Class II

Status

Terminated

Initiated

2013-10-11

Terminated

2016-03-10

Firm location

Plymouth, MN, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.