FDA Medical Device Recalls (openFDA)
Medtronic MiniMed: Medtronic MiniMed Paradigm Model 712
- Recall number
- Z-0010-05
- Recalling firm
- Medtronic MiniMed
- Product
- Medtronic MiniMed Paradigm Model 712
- Status
- Terminated
- Initiated
- 2004-09-14
- Posted
- not on file
- Terminated
- 2005-03-03
- Reason
- Several complaints of pumps exhibiting A47 alarms were received. Investigation revealed the alarms occurred when the pump attempted to display text that exceeded the maximum display length of the pump screen. The investigation revealed this only occurs when the pump is programmed to display information in Spanish.
- Root cause
- Other
- Action
- not on file
- Quantity
- 10,600
- Distribution
- Nationwide & Spain
- Lot, serial or model codes
- Paradigm model 712pumps with serial numbers that end in '-Dxx3' . Where 'x' can be any number or letter.
- 510(k) numbers
- ["K030531"]
- PMA numbers
- not on file
- Product code
- LZG
- Firm FEI
- 3003166194
- Firm city
- Northridge
- 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