Guidant Corporation Guidant CONTAK RENEWAL 3 (models H170, H173, H175), CONTAK RENEWAL 3 HE (models H177, H179) CONTAK RENEWAL 4 (models H190, H195), CONTAK RENEWAL 4 HE (models H197, H199). 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Guidant CONTAK RENEWAL 3 (models H170, H173, H175), CONTAK RENEWAL 3 HE (models H177, H179) CONTAK RENEWAL 4 (models H190, H195), CONTAK RENEWAL 4 HE (models H197, H199). 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
Brand
Guidant Corporation
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Devices that are implanted subpectorally with the serial number facing the ribs. Implant orientation is not reported to Guidant.
Guidant Corporation is recalling Guidant CONTAK RENEWAL 3 (models H170, H173, H175), CONTAK RENEWAL 3 HE (models H177, H179) CONTAK due to Guidant has received 2 reports of device malfunction associated with subpectoral implantation in an uncommon orientation (serial number facing ribs). . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Guidant has received 2 reports of device malfunction associated with subpectoral implantation in an uncommon orientation (serial number facing ribs). Repetitive mechanical stress in this orientation can result in Loss of shock therapy, Loss of pacing therapy (intermittent or permanent), Loss of telemetry, Programmer warning screen upon interrogation, and beeping.
Recommended Action
Per FDA guidance
The recall was initiated on May 15, 2006, with a press release and a letter to physicians. Physicians are asked to review the specific positioning of each device for patients implanted with affected models. This is a review of medical records to determine if the device is subpectoral. Then use of an AP radiograph on patients with a subpectoral implant to determine device orientation and if leads exit in a clockwise direction. In those cases, it''s recommended physicians advise the patient of the potential for failure, and follow-up at least once per quarter per device labeling and consider device replacement for larger muscle/active patients or for patients who regularly utilize therapy. Physicians are instructed to orient device with the serial number facing away from the ribs for future implants.
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