Z-0011-05

Medtronic MiniMed Paradigm Model 512

Name: Z-0011-05 Medtronic MiniMed Paradigm Model 512
Creator: Medtronic MiniMed
Published: 2004-09-14
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2004-09-14 / Terminated

FDA source

Medtronic MiniMed began a recall of Medtronic MiniMed Paradigm Model 512 on 2004-09-14. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0011-05
Status: Terminated
Initiated: 2004-09-14
Posted: 2015-06-25
Terminated: 2005-03-03
Recalling firm: Medtronic, Inc.
Product: Medtronic MiniMed Paradigm Model 512
Product code: LZG Pump, Infusion, Insulin
Reason for recall: 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.
FDA root cause: Other
Distribution: Nationwide & Spain
Product codes and lots: Paradigm model 512pumps with serial numbers that end in '-Axx4' . Where 'x' can be any number or letter.

Product code LZG

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)