Recall Z-0341-03 ยท DXY Implantable Pacemaker Pulse-Generator
St Jude Medical
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
| Date | Dec 18, 2002 (initiated Nov 4, 2002) |
| Status | Terminated |
| Reason | Potential loss of pacing function. Expansion of recalls Z-031-1 thru Z-036-1 |
| Root cause | Other |
| Action | 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. |
| Quantity | 1146 |
| Distribution | Nationwide and Australia, Austria, Belgium, Brazil, Canada, Cyprus, Czech Rep., France, Germany, Italy, Netherlands, Spain, Turkey, Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.