St. Jude Optisure Defibrillator Lead Recall Issued Over Insulation Problems

Several hundred St. Jude Optisure defibrillation leads are being recalled, due to a risk that the insulation may be defective and cause individuals to suffer unnecessary shocks to the heart. 

The Optisure Dual Coil Defibrillation Lead recall was announced by the FDA on January 21, after it was discovered that the small wires used to connect implantable cardiac defibrillators to the heart may have been compromised during the manufacturing process. This could result in cuts in the insulation layer of the shock coils.

St. Jude Medical originally sent a Medical Device Advisory letter to doctors in November 2015, warning about the risk of problems, indicating that a trim technique used to remove excess medical adhesive may have damaged the insulation around the SVC shock coils.

The leads are designed to monitor the heart rhythms and deliver electric shocks if needed to restore normal heart beats. However, insulation problems may cause the device to fail when it is needed or to deliver unnecessary shocks.

The recall impacts approximately 447 St. Jude Optisure Dual Coil Defibrillation Leads, with model numbers LDA220, LDA220Q, LDA230Q, and LDP220Q. The leads were sold worldwide, with about 281 sold in the U.S.

The leads were manufactured by St. Jude Medical’s Cardiac Rhythm Management Division, located in Sylmar, California.

Doctors have been instructed to contact their local Sales Representative or St. Judge Medical Technical Services at (800) 722-3774 with any questions.

The recall comes nearly a year after St. Jude agreed to pay $64.3 million to settle lawsuits over insulation problems with Riata lead defibrillators.

About 227,000 of the Riata lead wires were sold worldwide before the manufacturer acknowledged that the insulation surrounding the wire may be prone to decay and erode, leaving exposed wires inside patients. This has caused many users to experience unnecessary shocks, or for the defibrillator to fail.

In late 2010, St. Jude removed the leads from the market amid reports of insulation failure, and a warning letter was sent to doctors about the risk of problems in late 2011, which the FDA classified as a St. Jude Riata recall. However, it is estimated that nearly 80,000 of the leads remain active in patients in the United States, as the process of attempting to remove the lead is risky and doctors often recommend keeping the defective lead in place unless there is evidence that it has failed.