Recall Z-0890-06 ยท NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
Guidant Corporation
CONTAK RENEWAL 3 CRT-D (model no. H170, H175, H177, H179). Cardiac Resynchronization Therapy Defibrillator. Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. CONTAK RENEWAL 3 devices provide ventricular tachyarrhythmia and cardiac resynchronization therapies.
| Date | May 23, 2006 (initiated Sep 30, 2005) |
| Status | Terminated |
| Reason | Devices manufactured with batteries built on April 26 or 27, 2005, by a single operator, may have battery welds that may have been performed at settings outside of typical manufacturing specifications at the supplier. |
| Root cause | Other |
| Action | Guidant issued a Physicain letter, dated 10/25/05 to implanting/following physicians. The letter states the issues and reommends patient follow-up care every three months, as stated in published labeling. An Advisory Update, dated 12/20/05, was sent to physicians that describes the issue, states that here have been zero reports of battery weld failures on implanted devices and the results of laboratory testing (accelerated testing) in which they tried to induce the failure. The results of the testing induced 2 battery weld post failures. A projected rate of occurence was also given. Patie |
| Quantity | 180 |
| Distribution | Nationwide (AL, AZ, CA, CO, DC, FL, GA, HI, IA, IL, IN, KY, LA, MA, MI, MN, MO, MT, NC, ND, NE, NJ, NV, NY, OH, OK, PA, TN, TX, VA, WA, WI). OUS to include: Australia, France, Germany, India, Ireland, Israel, Italy, Netherlands, Norway, South Africa, Spain, Switzerland, Turkey, United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.