Z-0162-06

''Fine Tuning Your Pump'' booklet provided with Model MMT-515 AND MMT-715 INSULIN INFUSION PUMPS

Name: Z-0162-06 ''Fine Tuning Your Pump'' booklet provided with Model MMT-515 AND MMT-715 INSULIN INFUSION PUMPS
Creator: Medtronic MiniMed
Published: 2005-04-27
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2005-04-27 / Terminated

FDA source

Medtronic MiniMed began a recall of ''Fine Tuning Your Pump'' booklet provided with Model MMT-515 AND MMT-715 INSULIN INFUSION PUMPS on 2005-04-27. The reason FDA records is "The text description of how to perform insulin sensitivity testing and associated worksheet included in the booklet that is shipped with the Paradigm 515 and Paradigm 715 insulin pumps contained a basic flaw in that the...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0162-06
Status: Terminated
Initiated: 2005-04-27
Posted: 2005-11-18
Terminated: 2007-03-20
Recalling firm: Medtronic, Inc.
Product: ''Fine Tuning Your Pump'' booklet provided with Model MMT-515 AND MMT-715 INSULIN INFUSION PUMPS
Product code: LZG Pump, Infusion, Insulin
Reason for recall: The text description of how to perform insulin sensitivity testing and associated worksheet included in the booklet that is shipped with the Paradigm 515 and Paradigm 715 insulin pumps contained a basic flaw in that the blood glucose after the correction should be compared to the target glucose and it says compare to the beginning blood glucose in the procedure.
FDA root cause: Other
Action: All end users who recieved the model MMT-515 or MMT-715 pump that included the 'Fine Yuning Your Pump' workbook will be notified through a letter.
Quantity in commerce: Approximately 14,560
Distribution: Nationwide, Bahamas, Bermuda, Canada, Mexico, and Puerto Rico.
Product codes and lots: All Models MMT-515 and MMT-715 shipped between 10/01/2004 and 04/05/2005

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)