The FDA designated St. Jude's recall of the Optisure Dual Coil Defibrillation Leads as Class 1, the most severe classification reserved for products which can cause death or serious bodily harm. Malfunctioning leads could cause the wrong voltage to be delivered to the heart.
The leads are used in tandem with implantable cardioverter defibrillators, commonly known as ICDs. They are used to treat patients with arrhythmia, or abnormal heart beat. These devices monitor heartbeats and deliver voltage when an unusual heart rhythm is detected.
The recall applies to the worldwide distribution Optisure Dual Coil Defibrillation Leads falling under the following models: LDA220, LDA220Q, LDA230Q and LDP220Q. The recall only applies to around 450 devices worldwide. Although the risks are low, if you were implanted with one of the recalled leads you should contact you doctor in order to monitor the devices performance.
For more information, patients or physicians can visit www.sjm.com/optisureadvisory or call the St. Jude Medical customer service team 24 hours a day at (800) 328-9634.