Zoll Defibrillator Recall Lawsuit

ZOLL Defibrillators Receive a Class One Recall

In February 2009, the U.S. Food & Drug Administration (FDA) issued a Class One Recall for AED Plus Defibrillators. The recalled defibrillators are manufactured by ZOLL Medical Corporation. In addition to the recall, a letter was sent by ZOLL Medical Corporation to defibrillator users. A Class One Recall is the most serious recall the FDA can order; it means there is a “reasonable probability that use of these products will cause serious injury or death.”

The recalled defibrillators were manufactured by ZOLL from May 2004 to February 2009. They were distributed from May 2004 until February 9, 2009. Medical and emergency personnel to treat patients suffering from cardiac arrest use the defibrillators. The device determines the patient’s heart rhythm and then an electrical shock is delivered to the patient to restore a normal heart rhythm.

However, the defibrillators are defective and cannot perform as required. Some defibrillators are failing to deliver the electrical shock to the patient. When using the device, the words “change batteries” appears and the shock is never delivered. Failure to deliver the electric shock can result in failure to resuscitate the patient.

In the letter to defibrillator users, ZOLL stated it had received reports of problems with batteries. The problems often occurred after a period of time, usually more than 4 years, when the defibrillators were not used. ZOLL received one report where a defibrillation shock was not delivered and the patient died. Through ZOLL’s investigation, it found three more cases where the shock was not delivered. Of those three cases, one patient died. Their investigation has shown that some batteries develop a high internal resistance that interferes with the batteries performance. This causes increased time to charge the device, which can cause the defibrillator to terminate the charging cycle and the electrical shock is never delivered to the patient.

ZOLL recommends that users download new software for the defibrillators from their website and that the batteries be changed. ZOLL also recommended that the defibrillator batteries be changed every three years.

ZOLL is in the business of manufacturing medical devices. It manufactures other medical devices for cardiac pacing, defibrillation, circulation, ventilation and fluid resuscitation. From ZOLL’s headquarters in Chelmsford, Massachusetts, it sells products to over 140 countries, including Canada, Europe and Australia. This recall is widespread and affects roughly 180,000 defibrillators. If you believe that you or a loved one has suffered from a ZOLL defibrillator, you may want to speak with an attorney regarding a potential lawsuit. Please CLICK HERE for a free consultation.