On July 6, 2017, Oscor, Inc. issued a nationwide recall of Atar Reusable Extension Cables and Atar Disposable Extension Cables, which connect to external cardiac pacemakers or diagnostic machines.
During use, some Atar extension cables separated from the connector at the proximal end (the end nearer to the center of the body), the U.S. Food and Drug Administration (FDA) reports.
The failure occurs without warning, so patients dependent on cardiac pacing may suddenly be left unpaced without adequate warning to caregivers to quickly exchange the defective cable. A sudden pacing delay or failure may result in immediate and serious adverse health consequences, including death.
Parker Waichman LLP has experience in the injury risks posed by defective medical devices or equipment. The firm can advise individuals who believe they may have a legal claim against a manufacturer.
The FDA has identified this as a Class I recall, the FDA’s most serious medical device recall category. Use of the defective Atar cables may cause serious injuries or death.
In the company announcement of the recall, Oscor said its analysis of the returned cables revealed that a change in the manufacturing sequence was responsible for a fracture of the conductor cable from extensive use. These fractures, in turn, resulted in cable malfunction, causing interruption of the pacing system.
Oscor received a total of 66 complaints related to Atar cable failures. Five Atar malfunctions resulted in patient injuries. To date, no deaths have been reported; however the risk for possible injury is a concern if the cable separates during use. For patients dependent on cardiac pacing, an interruption of the pacing system could result in serious injury or death if not detected. Continuous monitoring is required.
Recalled Atar Cables
A full list of the recalled Oscor Atar Reusable Extension Cables and Oscor Atar Disposable Extension Cables can be found in the recall announcement on the U.S. Food and Drug Administration website. The recalled cables were manufactured between January 1, 2011 and April 12, 2017. The cables were distributed between January 11, 2011 and April 12, 2017. Oscor says 47,706 faulty Atar reusable and disposable cables were recalled.
What Hospitals and Health Care Providers Should Do
On June 23, 2017, Oscor sent affected hospitals and health care providers a Product Recall Letter informing them of the cables’ risks, and corrective actions they take to minimize the risk of patient harm.
The letter directed hospitals and health care providers to:
- Examine their inventory and immediately set aside all affected Atar cables (including any unused cables stored in alternate locations).
- Contact Oscor Customer Service for shipment and other relevant instructions for returning the recalled cables.
Atar Cable Use
Oscor’s Atar cable is an extension cable that connects an electrode/lead from the patient or another cable to a diagnostic machine or an external pacemaker. During use, however, some of the Atar cables were separating from the connector at the proximal end. Oscor attributed the defect causing the connector and wire separation to a change in the manufacturing. In the recall announcement, Oscor said it had received a total of 66 complaints related to the cable failure. Five of these reports said the cable failure resulted in patient injuries, though no patient deaths were reported. But the possibility of serious injury or death remains a concern if the cable separates during use. For patients who are dependent on cardiac pacing, an interruption in pacing, if not promptly detected and corrected, could prove fatal. Continuous monitoring is required.
The FDA encourages health care professionals and patients to report adverse events or side effects related to the use of Oscor Atar reusable and disposable extension cables products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
For Those Injured by Defective Oscor Atar Disposable or Reusable Extension Cables
If you or someone you know has been injured by the malfunction of an Atar disposable or reusable extension cable, please contact the attorneys at Parker Waichman LLP for a free, no-obligation case evaluation. To reach the firm, fill out the online contact form or call 1-800-YOURLAWYER (1-800-968-7529).