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 A700238Batch Number 41132434152911. Catalog Number A700240Batch Number 41132424124985
- 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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