FDA: Oscor recalls Atar extension cables

Editor's Note

The Food and Drug Administration (FDA) on July 6 announced the recall by Oscor Inc (Palm Harbor, Florida) of its Atar extension cables. The recall was initiated because, during use, some of the cables were separating from the connectors at the proximal end.

The Atar cable is an extension cable used to connect an electrode or lead from a patient or another cable to a diagnostic machine or an external pacemaker.

Oscor received 66 complaints, of which 5 resulted in patient injuries. Analysis of returned devices found a change in the manufacturing sequence that caused the problem.

For pacing dependent patients, an interruption of pacing system could result in serious injury or death if not detected. Posted 07/06/2017