Z-0884-03
Discovery Multiprogrammable Pacemaker, DDDR Model 1274
Boston Scientific Corporation / initiated 2003-05-06 / Terminated
Guidant Corp-Cpi Division began a recall of Discovery Multiprogrammable Pacemaker, DDDR Model 1274 on . The reason FDA records is "In a rare circumstance (fallback mode when high-rate atrial activity is detected), the battery gauge can over-estimate battery life". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-0884-03
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Boston Scientific Corporation
- Product
- Discovery Multiprogrammable Pacemaker, DDDR Model 1274
- Product code
- DXY Implantable Pacemaker Pulse-Generator
- Reason for recall
- In a rare circumstance (fallback mode when high-rate atrial activity is detected), the battery gauge can over-estimate battery life.
- FDA 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.
- Product codes and lots
- All Serial numbers
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