Oscor Inc. has issued a nationwide recall on ATAR Extension Cables used to connect an electrode/lead from a patient or another cable to a diagnostic machine or an external pacemaker because of a defect that can cause the wire to separate and fracture the conductor cable. This can lead to malfunction of the cable and cause an interruption of the pacing system. Oscar has received at lease 66 complaints related to this defect, five of which resulted in patient injuries. No deaths have been reported to date.
The ATAR cable is an extension cable with connectors on both sides. It is designed to connect with various receptacles or cable/leads, depending on the instrument being used. During use of some of the ATAR extension cables, the cable was separating from the connector at the proximal end. An 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.
For pacing-dependent patients, an interruption of pacing system could result in serious injury or death if not detected. Oscar is advising health care professionals to continuously monitor patients using these devices.
Any malfunctions of the device or adverse events related to these recalled extension cables should be reported to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: FDA Recall Notice