Medtronic MiniMed Paradigm Insulin Infusion Pumps for the following Paradigm models: MMT-511, MMT-512, MMT-712, MMT-515,

FDA device recall Z-1007-2007 · posted 2007-07-07 · Terminated

Recall details

Recalling firm

Medtronic MiniMed

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

Action taken

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.

Root cause

Other

Status

Terminated

Product code

LZG

Quantity affected

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,

Date initiated

2007-04-27

Date posted

2007-07-07

Date terminated

2012-09-19

Location

Northridge, CA

Related 510(k) clearances