Medical Device Safety and Recalls: Oscor Recalls ATAR Reusable and Disposable Extension Cable(s) Due to Risk of Cable Separation from Connector

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: Oscor Recalls ATAR Reusable and Disposable Extension Cable(s) Due to Risk of Cable Separation from Connector

Oscor Inc. is recalling specific lots of the ATAR Extension Cables due to a risk of the extension cables separating from the connectors during use.

Detachment of the extension cable and connectors can result in a delay and/or failure of cardiac pacing therapy for the patient. As the failure occurs without warning, it is possible that pacing-dependent patients may suddenly be left unpaced without adequate warning to their caregivers to quickly exchange the defective cable. Sudden pacing delay and/or failure may result in immediate and serious adverse health consequences, including death.

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