Guidant Defibrillator Recall Investigation

Share Article

The safety of heart defibrillators and pacemakers made by Guidant Corporation are under continued scrutiny.

Brown & Crouppen’s team of professional lawyers is currently investigating claims involving the failure of Guidant Corporation defibrillators and pacemakers. The Indianapolis-based company is a world leader in the design and development of cardiovascular medical products, but has recently recalled or issued warnings about more than 160,000 of its devices.

The latest warning, on Monday, July 18, 2005, involved nine pacemaker models made from 1997 to 2000. In at least 20 cases, a leaky seal caused the defibrillator to short out and fail, and in five of those instances the patient lost consciousness. The bad circuitry has also caused the heart device to fire up and pace at a high rate, putting a potentially fatal strain on a weak heart.

Guidant informed doctors that each of the estimated 28,000 defibrillators currently implanted in patients worldwide might need to be replaced. The affected models include:

  • Pulsar® Max Models 1170, 1171, 1270
  • Pulsar Models 0470, 0870, 0970, 0972, 1172, 1272
  • Discovery® Models 1174, 1175, 1273, 1274, 1275
  • Meridian® Models 0476, 0976, 1176, 1276
  • Pulsar Max II Models 1180, 1181, 1280
  • Discovery II Models 0481, 0981, 1184, 1186, 1187, 1283, 1284, 1285, 1286
  • Contak TR® Model 1241
  • Virtus Plus® II Models 1380, 1480
  • Intelis II Models 1483, 1484, 1485, 1384, 1385, 1349, 1499

A month earlier, on June 17, Guidant recalled almost 109,000 of its cardiac defibrillators. Of those, approximately 50,000 U.S. patients are believed to have one of the recalled defibrillators implanted. Guidant has stated that the devices have malfunctioned at least 45 times, causing two deaths. The malfunction causes damage to the device’s circuitry, potentially resulting in the inability to deliver the required shock during episodes of arrhythmia. The following implantable defibrillators were recalled:

  • Prizm 2 DR, Model 1861, manufactured on or before April 16, 2002

  • Contak Renewal, Model H135, manufactured on or before August 26, 2004
  • Contak Renewal 2, Model H155, manufactured on or before August 26, 2004

Two weeks later, on July 1, 2005, Guidant informed the FDA that it needed to recall another set of defibrillators, called the Ventak Prizm AVT, Vitality AVT, Renewal 3 AVT and Renewal 4 AVT. The company has said the devices are subject to a memory error, which may affect device performance. Nearly 24,000 of the devices are believed to be implanted worldwide.

Guidant has stated that it will cover the cost of a new pacemaker, plus $2,500 in any additional costs for replacement surgery beyond what Medicare or other health insurance would pay. To date, the company has made no provisions for covering the cost of the defibrillators.

Anyone with a cardiovascular product manufactured by Guidant Corporation may be at risk for serious health problems. Contact Brown & Crouppen today: 1(800) 536-HELP or http://www.GuidantRecallLawyers.com

About Brown & Crouppen

Brown & Crouppen has been building a reputation for success with personal injury clients for over 25 years. Today, we are one of mid-America’s largest personal injury law firms with over 70 legal professionals and five offices throughout Missouri and Illinois.

You can count on the lawyers of Brown & Crouppen for top-notch legal skills and our commitment to making the justice system work for our clients. If you have legal concerns and would like to benefit from the support of a strong team of legal professionals, please contact us online (http://www.brownandcrouppen.com) or call our office today at 1-800-536-HELP.

###

Share article on social media or email:

View article via:

Pdf Print

Contact Author

Diane Lawrence
Visit website