Defibrillation Leads Recalled
St. Jude Medical recalled their defibrillator connecting wires, called Optisure Dual Coil Defibrillation Leads, due to the possibility that the technology will fail and prevent the defibrillator from delivering electrical therapy to the patient. This risk of device failure depends on device programming and the depth of the cut, since the problem was caused by a manufacturing error that may have caused damage to the insulation layer of one of the shock coils.
The use of affected products may cause serious adverse health consequences, including patient injury or death. This recall was identified as a Class I recall by the U.S. Food and Drug Administration (FDA), meaning that use of these devices may cause serious injuries or death.
Defibrillation Leads Recalled – Product Information
According to the FDA Recall Press Release, “The Optisure Dual Coil Defibrillation Leads are implanted wires that connect a defibrillator to a patient’s heart. 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)”.
- Model numbers: LDA220, LDA220Q, LDA230Q, LDP220Q
- Manufacturing dates: March 12, 2014 to March 22, 2015
- Distribution dates: April 9, 2014 to October 20, 2015
- Devices recalled in the U.S.: 281 units
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