Cardiac defibrillators are implants used to shock a failing heart in patients with congestive heart failure, abnormally fast heart rhythms (tachycardia) or irregular heartbeats.
Guidant Corporation, the manufacturer of the most common type of defibrillator, has come under intense scrutiny since a 2005 recall of thousands of its implantable cardioverter defibrillator (ICD). The failing devices had a manufacturing defect that may cause the implant to short-circuit or malfunction.
After further investigation, the FDA has uncovered numerous reports of malfunctioning Guidant cardiac defibrillators that have led to serious side effects and death. The initial defibrillator recall was for the Ventak Prizm 2 DR, model 1861, manufactured on or before April 16, 2002. However, the Guidant recall now includes the following models:
- Ventak Prizm 2 DR (model 1861)
- Ventak Prizm AVT
- Contak Renewal (model H135)
- Contak Renewal 2 (model H155)
- Vitality AVT
- Renewal 3 AVT
- Renewal 4 AVT
Current cases against Guidant allege that the implant maker was aware of the faulty defibrillators and did not disclose the life-threatening defects until the FDA investigation and public scrutiny. Sadly, this type of negligence can have fatal results.
If you or someone you know has had a Guidant cardiac defibrillator implantation and has suffered serious adverse events, please contact a medical malpractice lawyer to discuss your legal options.