Recall Z-0896-03 ยท DXY Implantable Pacemaker Pulse-Generator
Guidant Corp-Cpi Division
Insignia Entra Multiprogrammable Pacemaker, DDDR Model 1298
| Date | May 29, 2003 (initiated May 6, 2003) |
| Status | Terminated |
| Reason | In a rare circumstance (fallback mode when high-rate atrial activity is detected), the battery gauge can over-estimate battery life. |
| Root cause | Other |
| Action | An 'Important Pacemaker Follow-up Information' letter dated May 6, 2003 gave recommendations for avoiding the problem and indicated that updated software to prevent the problem would be introduced. |
| Distribution | Nationwide in the United States and worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.