FDA Recall - Defective Guidant Pacemakers

   

In this section:

A Food and Drug Administration (FDA) classified Guidant pacemaker recall was issued for certain defibrillator models on June 17th, 2005. Included in the FDA recall were Guidant implanted cardioverter defibrillator (ICD) models and cardiac resynchronization therapy (CRT) devices.

The specific Guidant devices affected by the June 17th FDA recall included:

  • Prizm 2 DR, Model 1861 (manufactured prior to 04-16-02)
  • Contak Renewal, Model H135 (manufactured prior to 08-26-04)
  • Contak Renewal 2, Model H155 (manufactured prior to 08-26-04)

These devices were proven capable of developing an internal short circuit that would result in device failure. Two deaths have resulted from this malfunction because the device was unable to deliver a shock to the heart when needed.

Guidant pacemaker devices are implanted in the chest area where they monitor heart function. Accelerated heart rate (tachycardia) can be controlled by such devices. When functioning properly, cardiovascular medical devices can provide significant aid to patients suffering from heart rate/rhythm abnormalities. When defective, the Guidant devices provide a false sense of security to patients, putting them at risk of incurring a serious personal injury or death.

The FDA has reserved judgment on whether or not patients with one of the aforementioned Guidant devices should have it removed because of the risks involved with such an operation. Instead, the FDA recommends that patients should consult their doctor immediately to discuss the best course of action.

On July 18th, 2005, another FDA recall was issued for certain Guidant pacemaker models manufactured between November 25th, 1997 and October 26th, 2000. The recall resulted from a defective seal within certain Guidant pacemaker models that had proven capable of leaking, allowing moisture to negatively affect some of the device’s electronic circuits. The defective models included Pulsar, Discovery, Meridian, Contak, Virtus and Intelis devices.

Both the June 17th and July 18th FDA recalls were class 1 because the defective devices could potentially cause serious health problems or lead to patient death.

Guidant Recall - Updates

The UK Medicines and Healthcare Products Regulatory Agency issued a safety advisory update to an FDA advisory related to a defect affecting certain implantable heart devices. The defect related to a failure that could potentially inhibit the device’s ability to deliver “shocks” when needed.

On April 11th, 2007, a recall was issued for approximately 73,000 Guidant ICD and CRT devices. The recall resulted from a battery life defect that causes the rapid depletion device batteries. Of the 73,000 recalled Guidant devices, 19 were found to be affected by defective batteries. Guidant Corp. has stated that the battery-life defect has not yet resulted in death or serious injury.

Guidant Trial Set to Begin July 30, 2007

July 30th, 2007 marks the start of the long-awaited trial against Guidant Corp. related to a 2005 recall of ICD and pacemaker devices. The lawsuit reflects a combination of more than a thousand individual claims filed by patients affected by the recall of some 300,000 Guidant devices. Filed in the U.S District Court in Minnesota, the lawsuit alleges that Guidant Corp. willingly covered up known problems related to defective ICDs and pacemakers for a number of years in an effort to protect the company’s profits.

Food and Drug Administration - A Brief Introduction

The FDA is responsible for ensuring that a variety of products, spanning an array of markets are safe for public use/consumption. The FDA’s responsibilities include ensuring that:

  • Foods are safe, wholesome and sanitary.
  • Human/veterinary drugs, biological products and medical devices (like Guidant Pacemakers) are safe and effective.
  • Cosmetics are safe.
  • Electronic products capable of emitting radiation are safe.

In addition to regulation of the products themselves, the FDA is also involved in regulating the marketing of products following their approval in order to ensure that they are represented to the public in an informative, honest and accurate manner.

An FDA recall is typically a recommendation as opposed to an "order." The Federal Food, Drug, and Cosmetic Act does not authorize the FDA to order a recall unless a medical device, human tissue product or type of infant formula poses a risk to human health; under such circumstances, an FDA recall can be ordered. The FDA often requests a recall of a dangerous product if a manufacturer demonstrates an unwillingness to remove it themselves.

An FDA recall is classed based on the danger associated with the product in question:

  • FDA Recall - Class 1: A class 1 FDA recall is the most serious type of recall. If a product is believed to have a "reasonable probability" of causing serious personal injury or death, the FDA can issue a class 1 recall.
  • FDA Recall - Class 2: A class 2 FDA recall involves products that are believed capable of causing temporary health problems with minimal risk of serious injury.
  • FDA Recall - Class 3: A class 3 FDA recall is the least severe of the three, involving products that are unlikely to cause health problems or injury, but violate certain FDA manufacturing or labeling regulations.

The law offices of Aylstock, Witkin, Kreis & Overholtz have a great deal of experience in litigation associated with personal injuries incurred as a result of defective medical devices like Guidant pacemakers. If you or a loved one has been injured by a defective medical device (Guidant pacemaker, ICD or CRT), the Pensacola, Florida lawyers of Aylstock, Witkin, Kreis & Overholtz are waiting to hear from you to discuss all your legal recourse options.