Oscor Recalls ATAR Reusable and Disposable Extension Cable(s) Due to Risk of Cable Separation from Connector
The US Food and Drug Administration (FDA) is announcing the Class I Recall for the Oscor ATAR Reusable Extension Cable and the Oscor ATAR Disposable Extension Cable. Oscor's ATAR cable is an extension cable intended to connect an electrode/lead from a patient or another cable to a diagnostic machine or an external pacemaker. Follow the link below for a complete list of recalled model and lot numbers.
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.
On June 23, 2017, Oscor sent affected hospitals and health care providers a "Product Recall Letter" informing them of the device's risks, and corrective actions that should be implemented to minimize the risk of patient harm. The letter directed affected hospitals and health care providers to:
- Use the list provided with the letter to immediately inventory and set-aside all affected product (including unused product that is stored, or in alternate locations).
- Review, complete, sign, and return the acknowledgement form attached in the letter, directly to Oscor, Inc. at the fax number or e-mail on the form for immediate replacement (as applicable).
- Contact Oscor's Customer Service Team for shipment and other relevant instructions if their organization has affected cables to return.
Follow the link below for additional information.
Want to read the full alert and receive alert emails?