Oscor Inc. Issues Recall of TB – Temporary Bipolar Pacing Lead (Unshrouded 2 mm Pins Models)

Defect Levels Handbook

Throughout using some TB – Temporary Bipolar Pacing Leads, featuring the 2mm unshrouded connectors, the connector cap casing (see Picture 1, No. 2 Pin Cap and Cover) can slide and possibly expose the link cable. On occasion, this might cause the cable to be more prone to lack of connectivity or breakage through motion of the wires resulting in disruption of the pacing system. The analysis of these returned apparatus attributed the collapse to a design modification of the cap casing of their hooks. In the previous six decades, a total of four severe injuries were reported to Oscor that have been imputed to some connector cap error causing the direct connector to separate through use possibly resulting in a disruption of the pacing system.

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