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January 26, 2016: Optisure Dual Coil Defibrillation Leads Recalled Due to Manufacturing Error

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


If you are a loved one has been seriously injured by a recalled medical device, and you have a question concerning your legal rights, please submit our easy-to-use “Legal Case Evaluation Form”, or contact us toll free at 1-877-934-6274 for a free legal case evaluation.

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