ATAR Extension Cable Recall Issued Over Concerns Of Disconnections From Heart Therapy Devices
Nearly 50,000 cables used for cardiac pacing therapy are being recalled, due to a risk that they may unexpectedly detach, resulting in either a delay or failure in treatment that could result in serious adverse health consequences, including death.
An Oscor ATAR Extension Cables recall was announced on July 21, as result of problems where the extension cables and connectors may detach during use. To date, no injuries or fatalities have been recorded in relation to the recall.
The recalled devices are extension cables that are intended to connect to an electrode or lead that is connected to either a patient, another cable to a diagnostic machine, or an external pacemaker. The cables are designed to allow healthcare physicians to administer cardiac pacing therapy sessions on patients.
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Patients undergoing cardiac pacing therapy could be at serious risk of injury or death in the event the cable connections unexpectedly detach. Detachment of the connections will result in a delay or failure of cardiac pacing therapy, leaving the patient unpaced without adequate warning. Delays or total failure of cardiac pacing therapy could result in immediate and serious adverse health consequences for pacing-dependent patients.
On June 23, the manufacturing company Oscor Inc., sent hospitals and health care providers a “Product Recall Letter” informing them of the risks and how to mitigate patient harm by quarantining all affected products.
The recall affect Oscor ATAR Reusable Extension Cables and Oscor ATAR Disposable Extension Cables, that were manufactured by Oscor Inc., of Palm Harbor, Florida from January 1, 2011 through April 12, 2017. The devices were distributed throughout the United States to healthcare professionals and medical facilities from January 11, 2011 to April 12, 2017.
According to the FDA recall notice, an estimated 47,706 devices were distributed throughout the United States. For a full list of the recalled model and item numbers, please visit the FDA recall notice.
The recall has have been categorized as a Class I recall by the FDA due to the serious and potentially fatal health consequences that could occur if the extension cable connections detach unexpectedly during use.
Class I recalls represent the most serious type of recalls, indicating the products present a situation in which there is a reasonable probability that the use of or exposure to a volatile product will cause serious adverse health consequences or death.
Healthcare facilities and professionals should immediately discontinue use and set-aside all affected products and contact Oscor’s Customer Service Group at 727-937-2511 or email them at email@example.com for instructions on how to return the affected cables.
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