Z-0168-04

Paradigm Model 511 and 512 Insulin Infusion Pumps

Name: Z-0168-04 Paradigm Model 511 and 512 Insulin Infusion Pumps
Creator: Medtronic MiniMed
Published: 2003-08-29
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2003-08-29 / Terminated

FDA source

Medtronic MiniMed began a recall of Paradigm Model 511 and 512 Insulin Infusion Pumps on 2003-08-29. The reason FDA records is "Water ingresses into the device when in prolonged contact with water causing device to malfunction". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0168-04
Status: Terminated
Initiated: 2003-08-29
Posted: 2003-11-27
Terminated: 2005-09-02
Recalling firm: Medtronic, Inc.
Product: Paradigm Model 511 and 512 Insulin Infusion Pumps
Product code: LZG Pump, Infusion, Insulin
Reason for recall: Water ingresses into the device when in prolonged contact with water causing device to malfunction.
FDA root cause: Other
Action: The firm sent notifications to all pump users of record, all distributors and all certified pump trainers indications that the pumps should not be immersed in water. Canadian users were contacted by Medtronic Canada.
Quantity in commerce: Approximately 61,000 patients
Distribution: Nationwide and Canada
Product codes and lots: Codes are irrelevant

Product code LZG

K001829Class IIMinimed Paradigm Insulin Pump, Model 511Minimed, Inc. / cleared 2000-08-18

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)