Recall Z-0863-06 ยท NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
Guidant Corporation
CONTAK RENEWAL 3 RF (models H210, H215), CONTAK RENEWAL 3 RF HE (models H217, H219), CONTAK RENEWAL 4 RF (models H230, H235) CONTAK RENEWAL 4 RF HE (model H239) cardiac resynchronization therapy defibrillator (CRT-D), provide ventricular tachyarrhythmia and cardiac resynchronization therapies. Ventricular tachyarrhythmia therapy is for the treatment of ventricualar tachycardia (VT) and ventricula
| Date | May 16, 2006 (initiated Mar 11, 2006) |
| Status | Terminated |
| Reason | Guidant received 39 reports of devices that exhibited lower than expected battery voltage prior to implant; none of these devices were implanted. |
| Root cause | Other |
| Action | Affected physicians were sent an Urgent Medical Device Safety Information & Corrective Action letter, dated 05/11/06. A press release was issued March 13, 2006 The letter describes the issue and emphasizes the importance of checking battery voltage prior to implant as stated in device labeling. For implanted devices, continue normal follow-up. |
| Quantity | 8,879 |
| Distribution | Nationwide, Puerto Rico, Virgin Islands and to countries that include: Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Iran, Ireland, Israel, Italy, Luxembourg, Mexico, Netherlands, Norway, Portugal, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, United Arab Emirat |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.