Guidant Corp-Cpi Division Insignia Entra Multiprogrammable Pacemaker, DDDR Model 1296 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Insignia Entra Multiprogrammable Pacemaker, DDDR Model 1296
Brand
Guidant Corp-Cpi Division
Lot Codes / Batch Numbers
All Serial numbers
Products Sold
All Serial numbers
Guidant Corp-Cpi Division is recalling Insignia Entra Multiprogrammable Pacemaker, DDDR Model 1296 due to In a rare circumstance (fallback mode when high-rate atrial activity is detected), the battery gauge can over-estimate battery life.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
In a rare circumstance (fallback mode when high-rate atrial activity is detected), the battery gauge can over-estimate battery life.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026