Z-1007-2007

Medtronic MiniMed Paradigm Insulin Infusion Pumps for the following Paradigm models: MMT-511, MMT-512...

Name: Z-1007-2007 Medtronic MiniMed Paradigm Insulin Infusion Pumps for the following Paradigm models: MMT-511, MMT-512...
Creator: Medtronic MiniMed
Published: 2007-04-27
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2007-04-27 / Terminated

FDA source

Medtronic MiniMed began a recall of Medtronic MiniMed Paradigm Insulin Infusion Pumps for the following Paradigm models: MMT-511, MMT-512, MMT-712, MMT-515, MMT-715, MMT-522 and MMT-722 on 2007-04-27. The reason FDA records is "Exposure to Magnetic Resonance Imaging (MRI) has resulted in damage to the component that monitors and controls movement of the motor in the MiniMed Paradigm insulin infusion pump. Although there were alarms as a result...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1007-2007
Status: Terminated
Initiated: 2007-04-27
Posted: 2007-07-07
Terminated: 2012-09-19
Recalling firm: Medtronic, Inc.
Product: Medtronic MiniMed Paradigm Insulin Infusion Pumps for the following Paradigm models: MMT-511, MMT-512, MMT-712, MMT-515, MMT-715, MMT-522 and MMT-722
Product code: LZG Pump, Infusion, Insulin
Reason for recall: Exposure to Magnetic Resonance Imaging (MRI) has resulted in damage to the component that monitors and controls movement of the motor in the MiniMed Paradigm insulin infusion pump. Although there were alarms as a result of the damage, some users cleared these alarms and continued using the pump. Under such conditions, the pump will significantly over-deliver; potentially causing severe hypoglycemi
FDA root cause: Other
Action: Firm mailed Medical Device Safety letters on April 24, 2007, to healthcare professionals, existing pump users and MRI facilities reiterating the existing warning in the pump User Guide to avoid exposing the pump to MRI (or similar high strength electromagnetic fields) and strengthening previous warning by specifically mentioning the potential for over-delivery and severe hypoglycemia. Firm is also including an insert with this information with any Paradigm infusion pumps shipped to new customers.
Quantity in commerce: 334,000 Paradigm insulin pumps (approx)
Distribution: Worldwide: USA, US Virgin Islands, Antigua, Australia, Austria, Bahamas, Bahrain, Bermuda, Brazil, Canada, Chile, China, Columbia, Czech Republic, Denmark, Dominican Republic, Egypt, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Poland, Puerto Rico, Qatar, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela.
Product codes and lots: "All serial numbers" for the following Paradigm models: MMT-51 1, MMT-512, MMT-712, MMT-515, MMT-715, MMT-522 and MMT-722

Product code LZG

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)