EBI Field Action: Acknowledgement and Receipt Form
We have received complaints describing damage to the lead wire sheath (black cable) component and causing exposure of the wires. The photo above on the right shows an example of what this may look like. This could potentially lead to no therapeutic treatment signal being delivered to the electrodes, thereby resulting in a delay in treatment. Highridge Medical has received 1,020 non-reportable customer complaints (0.86% complaint rate) to date describing the issue, however, we have not received any reports of adverse events to date associated with this condition.
Please inspect your device’s lead wires for damage before each use. If found to be damaged, discontinue use and contact Customer Service at 1-800-526-2579 x 6000 for a complimentary replacement. Until your replacement lead wire arrives, you may continue device treatments using the second lead wire provided with your System.
As a recent user of this product, you should have received in the mail a letter outlining these details; please complete the information below as acknowledgment of this Medical Device Correction Notice.
If you have further questions or concerns after reviewing your notice, please call customer service at 1-800-526-2579 x 6000. Customer Service Representatives are available from 8:30 a.m. to 5:00 p.m. ET, Monday through Friday. At other times, please leave a clear message for a return call by the next business day. Alternatively, your questions may be emailed to: ebi.csorders@highridgemedical.com.