Device Information

COMPANY NAME OF DEVICE MAKER:
Boston Scientific / Guidant

RECALLED GUIDANT DEFIBRILLATOR MODELS:

Prizm 2 DR model 1861
Contak Renewal model H135 Contak Renewal 2 model H155
Ventak Prizm AVT
Vitality AVT
Renewal 3 AVT
Renewal 4 AVT ICD's
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

GUIDANT Recall NEWS

Boston Scientific / Guidant Recall: Questions & Answers
FDA Web site — August 10, 2007

FDA Update Statement on Boston Scientific/Guidant Pacemakers and Defibrillators
FDA Web site — July 11, 2006

FDA study reveals malfunctions in implanted heart defibrillators were on the rise well before Guidant recall
MSNBC News — Sept. 16, 2005

FDA Updates Consumers on Guidant Corporation’s Implantable Defibrillators
FDA Web site — July 2005

FDA Announces Guidant’s Class I Pacemaker Recall
FDA Web site — July 2005

FDA Issues Nationwide Notification of Recall of Certain Guidant Implantable Defibrillators and Cardiac Resynchronization Therapy Defibrillators
FDA Web site — June 2005

Defective Guidant Cardiac Defibrillators

CASE UPDATE: $240 Million Guidant Defibrillator Settlement
KCR clients who were injured by malfunctioning Guidant cardiac defibrillators will claim shares of the $240 million fund as part of a 2008 nationwide settlement.

On June 17, 2005, Boston Scientific / Guidant recalled nearly 80,000 of its cardiac defibrillators because of defects that could lead to serious injury and death. Reports indicate that approximately 38,000 of the recalled defibrillators were implanted in patients throughout the United States.

The first indication that there was a problem with Guidant defibrillators came in 2002, when officials detected a potential problem with the wiring of one defibrillator model. Since then, Guidant’s own medical reports admitted that at least 69 defibrillators malfunctioned, resulting in at least two deaths by mid 2005.

In March 2005, a 21-year-old college student with heart disease, suffered sudden death when the Guidant defibrillator implanted in his chest short-circuited. Guidant, which was acquired by Boston Scientific, acknowledged that the defibrillator had short-circuited.

Following the college student’s death, Guidant told the student’s doctors that it was aware of 25 other cases in which the defibrillator had the same flaw. However, at the time, Guidant had not seen a compelling reason to issue an alert to physicians because the unit’s failure rate was very low and replacing the devices might pose greater risks to patients.

Guidant said it would correct the flaw in future models and no warning was issued to doctors until May 2005, a week after The New York Times disclosed the problems.

Proven Results

• In a confidential settlement, our attorneys successfully resolved a case against Johnson & Johnson on behalf of over 200 individuals who alleged that they contracted post operative infections from sutures that had not been properly sterilized.
  
  
• In another case, we successfully resolved a case against a Johnson & Johnson subsidiary, Ethicon, Inc. on behalf of approximately 56 women who allege that they were injured by a defective medical device known as Intergel.

If you or a loved one has received a recalled Guidant medical device, contact one of our medical device attorneys to talk about your case. Please fill out and submit the contact form on this page for a free case evaluation or call us toll-free at (888) 285-3333.