Device recall: US Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and Cool Path Duo Ablation Catheter, MediGuide Enabled…

Class II FDA enforcement event 66597. Recall start date: 11 Oct 2013. Status in the FDA record: Terminated. Termination date: 10 Mar 2016.

Reason for recall, in the words of FDA

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).

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

St. Jude Medical started this device recall on 11 Oct 2013. The firm address in the FDA record is in Plymouth, MN. FDA put the recall in Class II. FDA event 66597 has 1 product record. The first FDA enforcement report date is 13 Nov 2013. The record gives the status Terminated, with the termination date 10 Mar 2016.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

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

Recalling firm

St. Jude Medical, Plymouth, MN.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 66597: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0174-2014	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…	59	Class II	Terminated	13 Nov 2013

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2013: 1,236
Share of these events in Class II: 90%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 15

Other events of the firm

Other FDA enforcement events of St. Jude Medical
Initiated	Product (first record)	Type	Class	Records
3 Feb 2025	CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 -CardioMEMS Backend Web A	Device	Class II	1
6 Nov 2024	Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000) (Which interfaces with CardioMEMS" Ho	Device	Class II	1
5 Oct 2024	CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Patient Electronics System (PES) REF CM1100 Merlin.net	Device	Class II	2
30 Apr 2024	St. Jude Medical Agilis NxT Steerable Introducer, REF 408309	Device	Class II	1
4 Oct 2023	CardioMEMS Patient Electronic System (PES), Model Number CM1100. Used for wirelessly measuring and monitoring pulmonary	Device	Class II	1
7 Feb 2023	CardioMEMS HF System Patient Electronics System (PES), Model number CM1000, The CardioMEMS HF System provides pulmonary	Device	Class II	4
7 Feb 2023	CardioMEMS HF System PA Sensor and Delivery System, Model Number CM2000, The CardioMEMS HF System provides pulmonary art	Device	Class II	3
25 Nov 2014	TactiSys Quartz Pack, PN-004 400. For percutaneous catheter radiofrequency (RF) ablation of atrial cardiac arrhythmias t	Device	Class II	1
14 Oct 2014	St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353	Device	Class II	1
14 Oct 2014	St Jude Medical, 10F Fast-Cath Trio" Hemostasis Introducer, REF # 406308, Sterile EO. The Fast-Cath Trio" Hemostasis Int	Device	Class II	1

St. Jude Medical: all 15 events

Official channels

FDA enforcement report Z-0174-2014The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 66597. https://recallregister.com/fda/ii/66597/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: US distribution: KS, MA, UT,TX, KY, OH.
What quantity of product is in FDA event 66597?: The FDA record gives this quantity: 59
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2013 have the same class?: 90% of the 1,236 device events that started in 2013 are in Class II.