Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0886-03

Discovery II Multiprogrammable Pacemaker, DDDR Model 1280

Boston Scientific Corporation / initiated 2003-05-06 / Terminated

Guidant Corp-Cpi Division began a recall of Discovery II Multiprogrammable Pacemaker, DDDR Model 1280 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-0886-03
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Boston Scientific Corporation
Product
Discovery II Multiprogrammable Pacemaker, DDDR Model 1280
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