Implantable heart defibrillators have been embedded in thousands of cardiac patients. They are intended to save lives by sending an electrical current to shock a rapidly abnormal heart back into rhythm. In June and December, 2005, the Food & Drug Administration announced product recalls involving Guidant heart defibrillators. These recalled devices involve the following Guidant models:
1.         Ventak Prizm 2
2.         Centak Renewal
3.         Ventak Prizm AVT
4.         Vitality AVT
5.         Renewal 3 and 4 AVT

Guidant Corp. has now admitted that many of these defibrillators were manufactured with serious design flaws that may cause them to malfunction in various ways; including short circuit, accelerated battery drainage or failure to operate during a life threatening arrhythmia. Consider the following:

!   In a ADear Doctor@ letter dated June 17, 2005, Guidant confirmed numerous reports of failure of the Ventak Prizm 2. They also admitted that the number of deaths associated with the defective defibrillators may be underestimated because defibrillators are not routinely examined or deprogrammed after a patient dies.

!   Recently discovered court documents in a lawsuit involving a patient death suggest that Guidant knew about these electrical malfunctions prior to 2005, yet kept selling and distributing the defective devices to hospitals until their existing inventory was sold off.

!    As of January, 2006, at least 35 clinical failures of Guidant Centak Renewal brand defibrillators had been documented, with many devices still in circulation.

!    Unfortunately, defibrillators rarely supply any advance warning of an impending failure.  There is no Awarning sign@ or test that predicts whether a particular device will fail in any individual patient. Living with a recalled defibrillator places cardiac patients in a difficult position. They must decide whether to undergo expensive and traumatic replacement surgery, or simply leave the defective device in place and thereby risk the possibility of a product failure at a critical moment.

If a recalled Guidant defibrillator was implanted in you or a family member, you may be entitled to compensation from Guidant. Depending on your State=s law, this could include compensation for the cost of removing the device, damages for pain and suffering, or other compensation for wrongful death. Remember that all states impose a statute of limitations, which require an injured person to timely investigate and file a claim within a certain time limit. Most courts can be expected to say that the limitations clock began ticking when you were notified that your device was recalled or had other reason to know it was defective, but all state laws are different.
Roven-Kaplan is investigating several serious cases of defibrillator failure. If the manufacturer or your doctor has contacted you about a recalled device or if you would like us to check to see if your defibrillator is on the recall list, please call us at 1-800-997-1505. Please have the following information available with you: Make, Model and Serial Number (if possible).