FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-0341-03
- Recalling firm
- St Jude 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
- Status
- Terminated
- Initiated
- 2002-11-04
- Posted
- 2002-12-18
- Terminated
- 2004-12-14
- 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.
- Lot, serial or model codes
- Serial numbers U6227335 to U6240907
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DXY
- Firm FEI
- 2017865
- Firm city
- Sylmar
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28