Recall Z-1288-06 ยท NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
Boston Scientific CRM Corp
Guidant CONTAK RENEWAL 3 (models H170, H175) CONTAK RENEWAL 3 HE (models H177, H179) 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 t
| Date | Jul 27, 2006 (initiated May 15, 2006) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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 |
| Quantity | 59 |
| Distribution | Nationwide including Puerto Rico. Worldwide, including Argentina, Belgium, Canada, Denmark, France, Germany, Greece, Ireland, Italy, Netherlands, New Zealand, Portugal, Spain, Syrian Arab Republic, United Arab Emirates |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.