Insignia Plus Multiprogrammable Pacemaker, DDDR Model 1295
FDA device recall Z-0893-03 · posted 2003-05-29 · Terminated
Recall details
- Recalling firm
- Guidant Corp-Cpi Division
- Reason for recall
- In a rare circumstance (fallback mode when high-rate atrial activity is detected), the battery gauge can over-estimate battery life.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DXY
- Distribution
- Nationwide in the United States and worldwide.
- Date initiated
- 2003-05-06
- Date posted
- 2003-05-29
- Date terminated
- 2005-11-18
- Location
- St Paul, MN
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