Guidant Corporation Guidant CONTAK RENEWAL 4 (models H190, H195) CONTAK RENEWAL; 4 HE (model H197). Cardiac Resynchronization Therapy Defibrillator (CRT-D). Sterile EO. Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Cardiac resynchronization therapy defibrillators (CRT-D) provide ventricular tachyarrhythmia and cardiac resynchronization therapies. Ventricular tachyarrhythmia therapy is for the treatment of ventricular tachycardia (VT) and ventricular fibrillation (VF), rhythms th Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Guidant CONTAK RENEWAL 4 (models H190, H195) CONTAK RENEWAL; 4 HE (model H197). Cardiac Resynchronization Therapy Defibrillator (CRT-D). Sterile EO. Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Cardiac resynchronization therapy defibrillators (CRT-D) provide ventricular tachyarrhythmia and cardiac resynchronization therapies. Ventricular tachyarrhythmia therapy is for the treatment of ventricular tachycardia (VT) and ventricular fibrillation (VF), rhythms th
Brand
Guidant Corporation
Lot Codes / Batch Numbers
model H190 serial numbers: 311739, 311740, 311742, 311743, 311744, 311745, 311747, 311748, 311751, 311769, 311811, 311834, 311850, 311852, 311853, 311884, 311895, 311900, . model H195 serial number: 353166. model H197 serial number: 310331.
Products Sold
model H190 serial numbers: 311739, 311740, 311742, 311743, 311744, 311745, 311747, 311748, 311751, 311769, 311811, 311834, 311850, 311852, 311853, 311884, 311895, 311900, . model H195 serial number: 353166. model H197 serial number: 310331.
Guidant Corporation is recalling Guidant CONTAK RENEWAL 4 (models H190, H195) CONTAK RENEWAL; 4 HE (model H197). Cardiac Resynchroni due to 77 distributed devices may have a cracked layer of insulation in a flexible hybrid circuit, leading to internal shorting during charging such as durin. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
77 distributed devices may have a cracked layer of insulation in a flexible hybrid circuit, leading to internal shorting during charging such as during routine capacitor formation or for defibrillation. This would likely render the device non-functional, resulting in no output and/or telemetry communications.
Recommended Action
Per FDA guidance
Guidant Sales Representatives are retrieving non-implanted devices April 10-12, 2006. If a device is implanted the physician is sent an Urgent Medical Device Safety Information & Corrective Action letter, April 11-14, 2006. This letter describes the issue, states that Guidant is retrieving all non-implanted devices and that Guidant is currently conducting tests on retrieved devices. Physicians will be advised once more information is available.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026