Oscor Inc has issued a recall on the ATAR cable which is an extension cable with connector(s) on both sides, designed to connect with various receptacles or cables/leads, depending on the instrument being used. The extension cable is intended to connect an electrode/lead from a patient or another cable to a diagnostic machine or an external pacemaker.
During the use of some ATAR extension cables, the cable was separating from the connector at the proximal end. The analysis of the returned devices revealed a change in the manufacturing sequence attributed to the connector and wire separation, causing a fracture of the conductor cable from extensive use. This event resulted in cable malfunction, causing interruption of the pacing system.
Oscor received a total of 66 complaints related to that failure mode, of which 5 resulted in patient injuries. No deaths were reported; however the risk for possible injury is a concern if the cable separates during use.
Healthcare professionals are encouraged to report any malfunction and/or adverse events related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
