Pulse Generators (aka pacemakers) Models include: Z-031-1 Meta DDR, Model 1256D Z-032-1 Tempo VR, Model 1102 Z-033-1 Tempo V, Model 1902 Z-034-1 Tempo DR, Model 2101 Z-035-1 Tempo D, Model 2902 Z-036-1 Meta, Model 1256
This recall has been terminated (originally issued December 18, 2002).
- Recall Initiated
- November 4, 2002
- Posted
- December 18, 2002
- Terminated
- December 14, 2004
- Recall Number
- Z-0341-03
- Quantity
- 1146
- Firm Location
- Sylmar, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Potential loss of pacing function. Expansion of recalls Z-031-1 thru Z-036-1
Distribution
Nationwide and Australia, Austria, Belgium, Brazil, Canada, Cyprus, Czech Rep., France, Germany, Italy, Netherlands, Spain, Turkey, Venezuela.
Lot / Code Info
Serial numbers U6227335 to U6240907
Root Cause
Other
Action Taken
Firm issued 'Dear Doctor' letters to following physicians which listed patient''s that the Doctor was responsible for. The letter informs of the situation regarding the potential loss of pacing function and recommends that the professional healthcare provider review and evaluate patients with the affected devices as soon as possible. Additional conditions to consider are specified for pacemaker dependent versus nondependent patients.