St. Jude Medical: Medical Device Recall in 2013 - (Recall #: Z-0174-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: October 11, 2013

Date Posted: November 13, 2013

Recall Number: Z-0174-2014

Event ID: 66597

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).

Status: Terminated

Product Quantity: 59

Code Information:

Catalog Number A700244 Batch Number 4113241. Catalog Number A700240 Batch Number 4113242.

Distribution Pattern:

US distribution: KS, MA, UT,TX, KY, OH.

Voluntary or Mandated:

Voluntary: Firm initiated