Boston Scientific CRM Corp These models are not available in the US. Guidant CONTAK RENEWAL 4 (models H190, H195). Cardiac Resynchronization Therapy Defibrillator (CRT-D). 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 that are a Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
These models are not available in the US. Guidant CONTAK RENEWAL 4 (models H190, H195). Cardiac Resynchronization Therapy Defibrillator (CRT-D). 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 that are a
Brand
Boston Scientific CRM Corp
Lot Codes / Batch Numbers
model H190, serial numbers: 301196, 301198, 301204, 301206 model H195, serial numbers: 306327, 306332, 306333, 306334, 306337, 306339, 306348, 306349, 306351, 306367, 306368, 306378, 306380, 306447
Products Sold
model H190, serial numbers: 301196, 301198, 301204, 301206 model H195, serial numbers: 306327, 306332, 306333, 306334, 306337, 306339, 306348, 306349, 306351, 306367, 306368, 306378, 306380, 306447
Boston Scientific CRM Corp is recalling These models are not available in the US. Guidant CONTAK RENEWAL 4 (models H190, H195). Cardiac Re due to Guidant has identified a pattern of premature battery depletion in devices manufactured with a single lot of capacitors from a single supplier. If fu. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Guidant has identified a pattern of premature battery depletion in devices manufactured with a single lot of capacitors from a single supplier. If function of this low voltage capacitor is compromised, the battery may deplete prematurely.
Recommended Action
Per FDA guidance
An Urgent Medical Device Safety Information & Corrective Action letter, dated May 12, 2006, was sent to physicians. The letter gave a description of the issue, clinical implications, rate of occurrence, devices affected and recommendation. Physicians are asked to follow-up with affected patients as soon as possible because ERI to EOL time may be shortened. Physicians are asked to contact Guidant for instructions on performing a baseline 'save to disk' and provide this information to Guidant. Guidant will be able to analyze the device memory data and estimate remaining longevity and provide individualized follow-up and replacement guidelines. Subsequent follow-up visits should continue to monitor for evidence of premature battery depletion.
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