Recall Z-1065-05 ยท NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
Guidant Corporation
CONTAK RENEWAL 3 DS HE, model H177 CRT-D Cardiac Resynchronization Therapy Defibrillator. Contents have been Sterilized with gaseous ethylene oxide. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, USA. Provides ventricular tachyarrhythmia and cardiac resynchronization therapies.
| Date | Aug 3, 2005 (initiated Jun 16, 2005) |
| Status | Terminated |
| Reason | Devices were manufactured with PEEK insulation material on the feedthrough wires and distributed prior to PMAS approval. |
| Root cause | Other |
| Action | Sales Representatives notified 06/16/05 to return devices in their area. |
| Quantity | 3 |
| Distribution | CA, IL, MI, MO, OR and PA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.