CLASS II ONGOING Device recall · Reported 12 Mar 2025 · FDA Enforcement Report

Paradigm insulin pump recalled by Medtronic MiniMed

Medtronic MiniMed is recalling Paradigm insulin pump, distributed nationwide in the US. The recall was initiated on 31 Jan 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll Lot Numbers; All UDI numbers

Quantity recalled41,404 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1257-2025
FDA event ID: 96200
Recalling firm: Medtronic MiniMed, Northridge, CA
Classification: Class II
Status: Ongoing
Recall initiated: 31 Jan 2025
FDA classified: 3 Mar 2025
Reported: 12 Mar 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Insulin Pumps & Glucose Monitors

Timeline

31 Jan 2025	Recall initiated by company
3 Mar 2025	Classified by FDA	+31 days
12 Mar 2025	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

Paradigm insulin pump, REF: MMT-754

Where it was distributed

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.

Nationwide Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts

Questions about this recall

Is Paradigm insulin pump recalled?

Yes. Medtronic MiniMed recalled Paradigm insulin pump on 31 Jan 2025. The recall is Class II and its status is Ongoing. Recall number Z-1257-2025.

Why was it recalled?

Which lots are affected?

All Lot Numbers; All UDI numbers

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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