On July 6, the U.S. Food and Drug Administration (FDA) announced the recall by Oscor Inc. of its Atar extension cables. The Florida-based device maker issued the recall on March 27, 2017 and was initiated due to a concern that during use, some of the cables were separating from the connectors at the proximal (near the point of attachment) end.
The Atar cable is an extension cable that connects an electrode or lead from a patient or another cable to a diagnostic machine or an external pacemaker. Manufacturer Oscor received 66 complaints, of which five resulted in patient injuries, but no deaths have been reported. For patients who are dependent on pacing, an interruption of the pacing system may result in serious injury or death if not detected. Continuous monitoring is essential.
“The analysis of the returned devices revealed a change in the manufacturing sequence attributed to the connector and wire separation, causing a fracture of the conductor cable from extensive use. This event resulted in cable malfunction, causing interruption of the pacing system,” the notice states.
The recall involves the Atar reusable model S and disposable model S extension cables. The affected cables have connectors on each side that are designed to connect to various receptacles or cables, depending on the instrument being used. The connector and wire separation caused a fracture of the conductor cable, which triggered the cable malfunction, causing interruption of the pacing system.
A total of 13,137 units were distributed throughout the United States including the Wright Patterson Air Force base in Ohio and to more than 20 countries globally, according to Medscape.
To minimize the potential for a connector to cable separation, or any other failure with the cables, Oscor requests the users follow instructions defined within the current instructions for use. The instructions indicate the recommended number of times for reuse and requirement for re-sterilization of the product to be conducted by the manufacturer.
Parker Waichman LLP is a nationwide, renowned personal injury law firm that has successful and extensive experience representing clients in defective medical device cases. The attorneys at the firm are available to answer questions from anyone seeking information for a potential lawsuit.
The FDA announced a Class II designation in September 2016 for a recall involving thousands of temporary lead pacing systems made by Medtronic, because there was the potential for them to connect to a hazardous voltage. The recall involved 11,697 of the devices that were in the U.S. The remaining devices had been distributed to countries worldwide.
The temporary transvenous pacing lead was meant for intracardiac pacing and/or EGM (electrogram) recording for up to seven days. This is a disposable system that includes an active fixation bipolar lead and a soft-tipped, lubricated guide catheter.
The recall was issued because the devices did not comply with design standards meant to prevent the lead from being connected to a possibly hazardous voltage, according to the FDA. A Medtronic spokesperson, Ryan Mathre, said in an emailed statement, “The electrical connectors on the leads do not have the proper insulation required by the standard.”
A Class II recall is the FDA’s medium-risk level recall. Class II is for a situation in which use of, or exposure to, the recalled product may cause temporary or medically reversible adverse health consequences. The probability of serious adverse health consequences or death is remote.
In March 2016, Medtronic’s Reveal LINQ insertable cardiac monitor (ICM) was issued a hazard alert due to premature triggering of a notification system in the monitoring device warning that the battery was running out of power, reported the International Business Times.
An insertable cardiac monitor is a small device, approximately the size of a key, that monitors the heart continuously and alerts the wearer of any abnormal heart rhythms. Despite the premature alert, the ICM would keep functioning normally, and the device’s battery would not be affected. Thirty days later, an End of Service status would be displayed, and all automatic wireless alerts and transmissions would be disabled. Remote transmissions could still be manually sent by the patient to the doctor, at that point. The monitor itself, was said to have a three-year life span.
Current Atar Recall
Healthcare professionals are advised to report any malfunction and/or adverse events related to the use of any Oscor Inc., device that has the Atar cable, to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
Do You Seek Legal Advice Concerning a Medical Device?
If you or someone you know has been affected by a medical device injury, you may have valuable legal rights. Parker Waichman LLP offers free, no-obligation case evaluations. We urge you to contact us at 1-800-YOURLAWYER (1-800-968-7529).