FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

Medical Device Supplier Initiates Recall of Bipolar Pacing Leads

Nov. 30, 2018
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Florida-based medical device company Oscar issued a Class I recall for certain lots of its temporary bipolar pacing leads.

The TB Unshrouded Bipolar Pacing Leads are used to stimulate or pace the heart to increase a patient’s heart rate. They are placed into a vein and advanced until the tip touches the inside of the heart.

The company said that in certain lots of the pacing leads, the connector cap housing may shift and expose the internal wire, risking loss of connectivity or breakage during cable movement that could prevent the external pulse generator from pacing, which could be fatal.

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