St. Jude Medical has announced the recall of the Optisure Dual Coil Defibrillation Leads because a manufacturing error may have damaged the insulation layer of one of the shock coils. This could prevent the defibrillator from delivering appropriate electrical therapy to the patient.
The Food and Drug Administration (FDA) has designated this a Class 1 recall, which means that use of the affected product may cause serious adverse health consequences, including injury or death.
The recall notice contains a list of affected product codes. The recalled defibrillation coils were manufactured from March 12, 2014 to March 22, 2015, and were distributed from April 9, 2014 to October 20, 2015.
The Optisure Dual Coil Defibrillation Leads are wires that connect an implanted defibrillator to a patient’s heart, the FDA explains. The defibrillator system senses the patient’s heart rhythm and delivers electrical pulses or shocks when it detects a faster than normal heart rate (tachycardia) or completely disorganized electrical activity (fibrillation). The defective Optisure coils may not deliver the needed electrical therapy.
In a letter to health care providers sent on January 22, 2016, St. Jude Medical provided recommendations to ensure proper functioning of the defibrillators.
- Review the patient’s record and identify if the patient is implanted with an Optisure lead connected to an implantable defibrillator that uses DynamicTx technology.
- If the implantable defibrillator uses DynamicTx technology, follow the setting instructions provided by St. Jude Medical in their medical device advisory to doctors, dated January 22, 2016.
- If the implantable defibrillator does not use DynamicTx technology, follow the extra steps outlined in the same medical device advisory.
- Enroll patients in Merlin.net patient care network.
Patients should ask their doctor if the implantable defibrillator uses DynamicTx technology. This technology allows the doctor to control the device and ensures that the defibrillator delivers patient therapy even if the lead is damaged.
Customers with questions about this recall may contact St. Jude Medical technical services at 1-800-722-3774.