Reported Nov 20, 2013 · Terminated

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

St. Jude Medical

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: St. Jude Medical · 5050 Nathan Ln N · Plymouth, MN · 55442-3209

Is this the product you have?

  • 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.
Lot codes and dates
    • Catalog Number A700238
    • Batch Number 4113243
    • 4152911. Catalog Number A700240
    • Batch Number 4113242
    • 4124985
Amount recalled
46

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 9, 2014 · Data as of Sep 19, 6:03 PM UTC

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