Z-0174-2014 Class II Terminated
FDA device recall Z-0174-2014 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 batches of Coolpath Duo Ablation Catheter MediGuide Enabled products and… The recall status is terminated (terminated Mar 10, 2016). Affected quantity: 59.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 13, 2013
- Initiation Date
- Oct 11, 2013
- Termination Date
- Mar 10, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 59
Product Description
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 for Recall
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).
Distribution Pattern
US distribution: KS, MA, UT,TX, KY, OH.
Code Information
Catalog Number A700244 Batch Number 4113241. Catalog Number A700240 Batch Number 4113242.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0174-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026