MiniMed insulin pump, REF: 670G (MMT-1760, MMT-1761… recallZ-1261-2025 · Medtronic MiniMed, Inc. · initiated Jan 31, 2025
Class II Open, Classified All recalls posted in March 2025
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic MiniMed, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-1261-2025
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Jan 31, 2025
- Posted by the FDA
- Mar 3, 2025
- Recalling firm
- Medtronic MiniMed, Inc.
- Quantity
- 100,074 units
- Product code
- OZP
- FDA submissions
- P160017
- Distribution
- 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.
Product description
MiniMed insulin pump, REF: 670G (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782)
Code information (models, lots, serial numbers)
All Lot Numbers; All UDI numbers
Other devices under the same FDA submission
75 devices cleared under P160017 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- MiniMed® 670G MMT-1780KPKMedtronic Minimed, Inc. · Artificial pancreas device system, single hormonal control3 recalls78 deaths55,723 reports
- MiniMed® 670G MMT-1780KPKMedtronic Minimed, Inc. · Automated insulin dosing device system, single hormonal control2 recalls51 deaths33,713 reports
- MiniMed®670G MMT-1780KPKMedtronic Minimed, Inc. · Artificial pancreas device system, single hormonal control3 recalls39 deaths28,789 reports
- MiniMed® 670G MMT-1780KLMedtronic Minimed, Inc. · Automated insulin dosing device system, single hormonal control3 recalls8 deaths8,353 reports
- MiniMed® 670G MMT-1780KMedtronic Minimed, Inc. · Artificial pancreas device system, single hormonal control3 recalls7 deaths6,776 reports
- MiniMed® 670G MMT-1780KPKMedtronic Minimed, Inc. · Automated insulin dosing device system, single hormonal control3 recalls10 deaths4,325 reports
- Guardian™ Sensor (3) MMT-7020AMedtronic Minimed, Inc. · Automated insulin dosing device system, single hormonal control1,304 reports
- MiniMed® 670G MMT-1780KLMedtronic Minimed, Inc. · Artificial pancreas device system, single hormonal control3 recalls1 death958 reports
- Enlite ® MMT-7008AMedtronic Minimed, Inc. · Automated insulin dosing , threshold suspend994 reports
- MiniMed® 670G MMT-1780KLMedtronic Minimed, Inc. · Automated insulin dosing device system, single hormonal control3 recalls2 deaths783 reports
- MiniMed® 630G MMT-1715KMedtronic Minimed, Inc. · Automated insulin dosing device system, single hormonal control3 recalls8 deaths781 reports
- MiniMed® 670G MMT-1780KLMedtronic Minimed, Inc. · Automated insulin dosing device system, single hormonal control2 recalls1 death823 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 96200).
- Z-1256-2025 · Open, ClassifiedParadigm insulin pump, REF: MMT-522, MMT-523, MMT-551, MMT-722, MMT-723, MMT-751
- Z-1259-2025 · Open, ClassifiedMiniMed insulin pump, REF: 630G (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
- Z-1265-2025 · Open, ClassifiedMiniMed insulin pump, REF: 770G (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)
- Z-1266-2025 · Open, ClassifiedMiniMed insulin pump, REF: 780G (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896)
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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