St. Jude Medical Recalls Safire Duo Ablation Catheters Due to Connector Error
St. Jude Medical is voluntarily recalling 46 Safire Duo Ablation Catheters because they have a cable connector configuration that differs from the intended design.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is a voluntary notification regarding a configuration error with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
St. Jude Medical Cardiovascular and Ablation Technologies Division is performing a voluntary notification regarding selected batches of the Safire Duo Ableter MediGuide Enabled. The affected units are intended for creating endocardial lesions during cardiac ablation procedures for the treatment of typical atrial flutter.
The recall is due to a cable connector configuration that is different than intended. The source text does not report any illnesses, injuries, or deaths associated with these units.
A total of 46 units were distributed nationwide, including the states of Kentucky, Ohio, Texas, Massachusetts, and North Carolina. The affected catalog numbers are A700238 and A700240, with specific batch numbers listed in the agency record. Healthcare providers and patients should contact St. Jude Medical for further instructions.
The recalled product
- 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.
- Manufacturer
- St. Jude Medical
- Hazard
- Affected units
- 46
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Catalog Number A700238
- Batch Number 4113243
- 4152911. Catalog Number A700240
- Batch Number 4113242
- 4124985.
Distribution
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