Recall Z-1192-06 ยท NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
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 tach
| Date | Jul 4, 2006 (initiated May 15, 2006) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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 conside |
| Quantity | 54,971 devices have been distributed however this only affects those that have been implanted subpectorally with the ser |
| Distribution | Nationwide, US Virgin Islands, Puerto Rico and worldwide to include: Argentina, Aruba, Australia, Austria, Barbados, Belgium, Bermuda, Brazil, Canada, Cayman Islands, Chile, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greec |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.