FDA Medical Device Recalls (openFDA)
Medtronic MiniMed: 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
- Recall number
- Z-1007-2007
- Recalling firm
- Medtronic MiniMed
- 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
- Status
- Terminated
- Initiated
- 2007-04-27
- Posted
- 2007-07-07
- Terminated
- 2012-09-19
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- "All serial numbers" for the following Paradigm models: MMT-51 1, MMT-512, MMT-712, MMT-515, MMT-715, MMT-522 and MMT-722
- 510(k) numbers
- ["K001829","K030531","K031390","K040676","K053177"]
- PMA numbers
- ["P980022S16"]
- Product code
- LZG
- Firm FEI
- 3003166194
- Firm city
- Northridge
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28