Medical device company Oscor is recalling the ATAR Reusable Extension Cable and the ATAR Disposable Extension Cable because of a defect that may cause serious harm to patients. The cables are intended to connect an electrode or lead from a patient or another cable to a diagnostic machine or an external pacemaker. Oscor is recalling the cables because there is a risk of the extension cables separating from the connectors during use.
Detachment of the extension cable and connectors can cause 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.
A total of 47,706 cables in the U.S. are affected by the recall. They were distributed nationwide from Jan. 11, 2011, to April 12, 2017.
Oscor has sent letters to hospitals and health care providers who have affected devices and informed them of this issue and recall. The letter instructs them to immediately check their inventory for affected devices and set aside them aside.
The recall was initially issued in March 2017, and was expanded in June 2017. This is the third time Oscor is notifying hospitals and health care providers about this recall.
Any adverse events or quality issues regarding these recalled 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