Pulse Generators (aka pacemakers) Models include: Z-031-1 Meta DDR, Model 1256D Z-032-1 Tempo VR, Model 1102 Z-033-1 Tem
FDA device recall Z-0341-03 · posted 2002-12-18 · Terminated
Recall details
- Recalling firm
- St Jude Medical
- Reason for recall
- Potential loss of pacing function. Expansion of recalls Z-031-1 thru Z-036-1
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DXY
- Quantity affected
- 1146
- Distribution
- Nationwide and Australia, Austria, Belgium, Brazil, Canada, Cyprus, Czech Rep., France, Germany, Italy, Netherlands, Spain, Turkey, Venezuela.
- Date initiated
- 2002-11-04
- Date posted
- 2002-12-18
- Date terminated
- 2004-12-14
- Location
- Sylmar, CA
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