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Terminated

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

FDA Recall Z-1007-2007 · Posted 2007-07-07

Recalling FirmMedtronic MiniMed
Recall StatusTerminated
Product CodeLZG
Date Initiated2007-04-27
Date Terminated2012-09-19
Product Quantity334,000 Paradigm insulin pumps (approx)

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

Firm 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.

Root Cause

Other

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K053177MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712EMedtronic Minimed · 2006-01-31K040676MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODELS MMT-515 AND MMT-715Medtronic Minimed · 2004-05-21K031390MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712Minimed, Inc. · 2003-07-23K030531MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP AND THE BD PARADIGM LINK GLUCOSE METERMinimed, Inc. · 2003-06-17K001829MINIMED PARADIGM INSULIN PUMP, MODEL 511Minimed, Inc. · 2000-08-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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