Boston Scientific Recall of Defective Guidant Pacemakers and Defibrillators

   

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Medical device manufacturers Boston Scientific Corp. issued a recall for certain Guidant pacemakers and defibrillators on Monday June 26th, 2006. Having purchased the Indianapolis-based Guidant Corporation in April of 2006 for an approximate sum of $28 Billion, Boston Scientific is now liable for injuries caused by all Guidant brand medical devices.

Since June 2005, Guidant Corp. has been forced to issue safety warnings or recalls for more than 88,000 Guidant defibrillators and more than 200,000 Guidant pacemakers. Boston Scientific Corp. has unfortunately inherited the liabilities associated with these Guidant products, defects of which have been linked with seven deaths.

This most recent Guidant pacemaker / defibrillator recall involves six models, 27,000 of which have already been implanted worldwide. The defect relates to potentially faulty low-voltage capacitors that are responsible for storing the electrical charges required to administer treatments for tachycardia / bradycardia.

The recalled models include:

  • Ventak Prizm 2 defibrillators
  • Vitality defibrillators
  • Vitality 2 defibrillators
  • Contak Renewal TR/TR2 CRTs
  • Insignia pacemakers
  • Nexus pacemakers

Thus far, there have not been any deaths caused by defects affecting the aforementioned Guidant pacemakers and defibrillators. Of the five reported cases of defective devices, only two have had serious effects, causing temporary unconsciousness. Four of the five cases were discovered post-implant, requiring their surgical removal; the fifth case was discovered during implant and replaced.

Defective Pacemaker Advisory Update

In March of 2007, the UK Medicines and Healthcare Products Regulatory Agency issued an advisory update to the FDA advisory that spanned March of 2004 to January of 2007. This most recent safety advisory was issued in regards to a “charge time” defect affecting some implantable heart devices that could potentially cause a delay in their ability to deliver necessary shocks. While some devices have been replaced as a result of the defect, there have been no injuries reported as a result.

On April 11th, 2007, Guidant issued a recall for approximately 73,000 ICD and CRT devices. The recall resulted from a battery life defect that causes the rapid depletion of device batteries. Batteries designed to last two (+) years were depleting as quickly as three months after implantation. Of the approximately 73,000 recalled Guidant devices, 19 were found to be affected by the battery-life defect. Guidant has stated that the defect has not yet resulted in any deaths or serious injuries.

The safety advisory comes on the heels of a slew of pacemaker and ICD recalls in 2005 issued by Guidant and related manufacturers.

January 4, 2008 Update: Boston Scientific has identified additional Vitality implantable cardioverter defibrillator models that are susceptible to device malfunction. This most recent update highlights the orientation of placement for subpectoral ICD devices. When certain ICD models are implanted with the serial number directed towards the ribcage, their device leads exit in a clockwise direction. This is not ideal. It has been determined that such an orientation makes the defective ICD models more susceptible to malfunction.

The optimal placement of subpectoral ICD devices requires that a device’s serial number face away from the ribcage, allowing the leads to exit in a counter clockwise direction. ICD devices placed correctly have not been associated with malfunction.

The models included in the January 4, 2008 update include:

  • Vitality 2 EL DR/VR (T167/T177)
  • Vitality EL (T127)
  • Vitality DR+ (1872)

Defective Pacemaker and ICD Lawsuits

Personal injury litigation targeting the Guidant brand has been rooted in Guidant Corp.'s apparent failure to effectively notify doctors, governmental regulators and patients of their defective products. Although Boston Scientific has vowed to perform better in this regard, the company cannot escape the liabilities into which it has placed itself through the purchase of Guidant Corp. If you or a loved one has been harmed as a result of a defective Guidant pacemaker or defibrillator, you may be entitled to receive compensation from Boston Scientific. Contact our defective medical device lawyers at the law offices of Aylstock, Witkin, Kreis & Overholtz at (888) 255-AWKO (2956) to learn more about personal injury victims' rights.