Z-0341-03

Pulse Generators (aka pacemakers) Models include: Z-031-1 Meta DDR, Model 1256D Z-032-1 Tempo VR, Model 1102...

Name: Z-0341-03 Pulse Generators (aka pacemakers) Models include: Z-031-1 Meta DDR, Model 1256D Z-032-1 Tempo VR, Model 1102...
Creator: St Jude Medical
Published: 2002-11-04
License: https://open.fda.gov/license/

Abbott Medical / initiated 2002-11-04 / Terminated

FDA source

St Jude Medical began a recall of 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... on 2002-11-04. The reason FDA records is "Potential loss of pacing function. Expansion of recalls Z-031-1 thru Z-036-1". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0341-03
Status: Terminated
Initiated: 2002-11-04
Posted: 2002-12-18
Terminated: 2004-12-14
Recalling firm: Abbott Medical
Product: 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
Product code: DXY Implantable Pacemaker Pulse-Generator
Reason for recall: Potential loss of pacing function. Expansion of recalls Z-031-1 thru Z-036-1
FDA 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 in commerce: 1146
Distribution: Nationwide and Australia, Austria, Belgium, Brazil, Canada, Cyprus, Czech Rep., France, Germany, Italy, Netherlands, Spain, Turkey, Venezuela.
Product codes and lots: Serial numbers U6227335 to U6240907

Product code DXY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)