St. Jude Medical: Medical Device Recall in 2013 - (Recall #: Z-0187-2014)

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:

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 Classification:

Class II

Date Initiated: October 11, 2013

Date Posted: November 20, 2013

Recall Number: Z-0187-2014

Event ID: 66574

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.

Status: Terminated

Product Quantity: 46

Code Information:

Catalog Number A700238, Batch Number 4113243, 4152911. Catalog Number A700240, Batch Number 4113242, 4124985.

Distribution Pattern:

Nationwide Distribution including the states of KY, OH, TX, MA, and NC.

Voluntary or Mandated:

Voluntary: Firm initiated