Device recalls

MiniMed insulin pump, REF: 770G (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)

Medtronic MiniMed, Inc. · All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to c…

Open, ClassifiedDevice DesignZ-1265-2025
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Cfres ID
212337
Product res number
Z-1265-2025
Event date initiated
2025-01-31
Event date posted
2025-03-03
Recall status
Open, Classified
Res event number
96200
Product code
OZP
Product description
MiniMed insulin pump, REF: 770G (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)
Code info
All Lot Numbers; All UDI numbers
Firm FEI number
3003166194
Recalling firm
Medtronic MiniMed, Inc.
Address 1
18000 Devonshire St
City
Northridge
State
CA
Postal code
91325-1219
Additional info contact
Medtronic 24-Hr Technical Support 1800-646-4633 Ext. 1
Root cause description
Device Design
Product quantity
106,289 units
Reason for recall

All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to changes in air pressure, which can be found during airplane take-off or landing. An unexpected additional dose of insulin, which can occur during take-off, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An unexpected under-delivery of insulin, which can occur during landing, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

Action

On January 31, 2025, Medtronic MiniMed issued a "Urgent Medical Device Correction" notification to all affected consignees. The notification was distributed via: e-mail, certified mail, SMS text message or phone call. 1. Monitor Your Glucose Levels: 2. Discuss how to prepare for situations like this with your healthcare professional. 3. Respond to Alerts and Symptoms. 4. Please acknowledge that you have read and understood this notification and have followed the actions listed in this letter by either completing and returning the confirmation form, scanning the QR code below with your phone or tablet, or by visiting [https://info.medtronicdiabetes.com/pump-delivery-volume] to acknowledge this communication.

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY and the countries of Algeria, Andorra, Argentina, Armenia, Aruba, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Plurinational State Of Bosnia, Herzegovina , Botswana, Brazil, Brunei, Darussalam, Bulgaria, Cambodia, Canada, Canary Islands, Cayman, Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Gibraltar, Greece, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Islamic, Republic Of Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Latvia, Lebanon, Libya, Liechtenstein, Lithuania, Luxembourg, Malawi, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Republic Of Montenegro, Morocco, Namibia, Netherlands, New Caledonia, New Zealand, North Macedonia, Northern Ireland, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion Romania, Russia, Saint Pierre And Miquelon, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sudan, Sweden, Switzerland, Taiwan, Tanzania, United Republic Of Thailand, Trinidad And Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Bolivarian Republic Of Vietnam, Yemen, Zimbabwe.

PMA numbers
P160017
Harmonized identifiers (openFDA)
Device name
Automated Insulin Dosing Device System, Single Hormonal Control
Medical specialty description
Unknown
Device class
3
PMA number
P160017
Registration number
3011393376, 3006371704, 3009171251, 3009882464, 3014498598, 1000134386, 3011121740, 3038419886, 3004167884, 1810909, 2134850, 2032227, 3012118659, 3014353045, 3042027705
FEI number
3003166194, 3011393376, 3006371704, 3014498598, 3009882464, 1000134386, 3038419886, 3004167884, 3006759904, 1810909, 3010700165, 3012118659, 3014353045, 3003007876, 3042027705
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.