Z-0174-2014Class II

US Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and Cool Path Duo Ablation Catheter, MediGuide...

Name: Z-0174-2014 US Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and Cool Path Duo Ablation Catheter, MediGuide...
Creator: St. Jude Medical
Published: 2013-10-11
License: https://open.fda.gov/license/

Abbott Medical / initiated 2013-10-11 / Terminated / root cause: labeling and UDI

FDA source

St. Jude Medical began a recall of US Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and Cool Path Duo Ablation Catheter, MediGuide Enabled REF A700244, Rx only, Sterile EO. The... on 2013-10-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0174-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-11
Posted: 2013-11-06
Terminated: 2016-03-10
Recalling firm: Abbott Medical
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.
Product code: OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
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).
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: The firm, St. Jude Medical (SJM), sent a "Urgent Medical Device Notice" dated 11 October 2013 to its consignees. The letter described the problem, the product involved in the recall and the actions to be taken. The consignees were instructed to discard the IFU received with the batches and replace it with the IFU received in conjunction with the notification letter. SJM has determined that it is acceptable to continue using these devices as long as the product is used in accordance with the IFU. If you have any questions, contact Vice President, Quality, at 651-756-5402.
Quantity in commerce: 59
Distribution: US distribution: KS, MA, UT,TX, KY, OH.
Product codes and lots: Catalog Number A700244 Batch Number 4113241. Catalog Number A700240 Batch Number 4113242.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0174-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0174-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-13	2013-11-06

Product code OAD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)