Z-0187-2014Class II

Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and A700238, Rx only, Sterile EO. Intended for...

Name: Z-0187-2014 Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and A700238, Rx only, Sterile EO. Intended for...
Creator: St. Jude Medical
Published: 2013-10-11
License: https://open.fda.gov/license/

Abbott Medical / initiated 2013-10-11 / Terminated

FDA source

St. Jude Medical began a recall of Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and A700238, Rx only, Sterile EO. Intended for creating endocardial lesions during cardiac ablation... 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 batched of Safire Duo Ablation Catheter MediGuide Enabled. These units have a cable connector...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0187-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-11
Posted: 2013-11-08
Terminated: 2014-06-09
Recalling firm: Abbott Medical
Product: Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and A700238, Rx only, Sterile EO. Intended for creating endocardial lesions during cardiac ablation procedures (mapping, stimulation and ablation) for the treatment of typical atrial flutter.
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 batched of Safire Duo Ablation Catheter MediGuide Enabled. These units have a cable connector configuration that is different than intended.
FDA root cause: Process change control
Action: Consignees were sent a St. Jude Medical "Urgent Medical Device Notice" dated 11 October 2013. The letter was addressed to Cath lab manger / Risk Manger. The letter described the problem and the product involved in the recall. The letter stated that it is acceptable to continue using these devices as long as the product is used in accordance with the IFU.
Quantity in commerce: 46
Distribution: Nationwide Distribution including the states of KY, OH, TX, MA, and NC.
Product codes and lots: Catalog Number A700238, Batch Number 4113243, 4152911. Catalog Number A700240, Batch Number 4113242, 4124985.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0187-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0187-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-08

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)