Z-1259-2025Class II

MiniMed insulin pump, REF: 630G (MMT-1714, MMT-1715, MMT-1754, MMT-1755)

Name: Z-1259-2025 MiniMed insulin pump, REF: 630G (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
Creator: Medtronic MiniMed, Inc.
Published: 2025-01-31
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2025-01-31 / Open, Classified / root cause: design

FDA source

Medtronic MiniMed, Inc. began a recall of MiniMed insulin pump, REF: 630G (MMT-1714, MMT-1715, MMT-1754, MMT-1755) on 2025-01-31. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1259-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-01-31
Posted: 2025-03-03
Recalling firm: Medtronic, Inc.
Product: MiniMed insulin pump, REF: 630G (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
Product code: OZO Automated Insulin Dosing , Threshold Suspend
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.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 70587 units
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 codes and lots: All Lot Numbers; All UDI numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1259-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1255-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-12	2025-03-03
Z-1256-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-12	2025-03-03
Z-1257-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-12	2025-03-03
Z-1258-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-12	2025-03-03
Z-1259-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-12	2025-03-03
Z-1260-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-12	2025-03-03
Z-1261-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-12	2025-03-03
Z-1262-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-12	2025-03-03
Z-1263-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-12	2025-03-03
Z-1264-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-12	2025-03-03
Z-1265-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-12	2025-03-03
Z-1266-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-12	2025-03-03

Product code OZO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)