Z-1751-2026Class II

MiniMed 530G Insulin Pump (MMT-551, MMT-751)

Name: Z-1751-2026 MiniMed 530G Insulin Pump (MMT-551, MMT-751)
Creator: Medtronic MiniMed, Inc.
Published: 2026-02-13
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2026-02-13 / Open, Classified / root cause: design

FDA source

Medtronic MiniMed, Inc. began a recall of MiniMed 530G Insulin Pump (MMT-551, MMT-751) on 2026-02-13. FDA classified it as Class II and gives the reason as "All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the...". 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-1751-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-02-13
Posted: 2026-04-02
Recalling firm: Medtronic, Inc.
Product: MiniMed 530G Insulin Pump (MMT-551, MMT-751)
Product code: OZO Automated Insulin Dosing , Threshold Suspend
Reason for recall: All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
Root cause tag: design
FDA root cause: Device Design
Action: On 2/13/2026, communications began via email, SMS, certified postal mail, and in-app push notifications. Correction notices were sent informing customers of the following: User Guides will be updated to include: "It is important to keep the location of your pump stable relative to your infusion site. Do not wear or place your pump more than 14 in (35.5 cm) above your infusion site. Doing so can cause an over-delivery of insulin, which may result in hypoglycemia." User guides that are updated will be available at: https://www.medtronicdiabetes.com/download-library visit https://info.medtronicdiabetes.com/pump-placement for affected user guide versions. Required Actions: Keep the location of your insulin pump close to your infusion site. - If you need to raise the pump above your infusion site, such as when a parent or caregiver is using the pump for a child, limit the time that the pump is held above the infusion site. - Pay attention to any alerts from your pump as well as symptoms of hypoglycemia and hyperglycemia; follow your healthcare professional's treatment instructions in these situations. - If you have any concerns about how this may impact insulin delivery and blood glucose, please contact your healthcare professional. You may also contact firm at 1-855-587-4950 with any questions about this notification. -Complete and return the acknowledgement form by visiting https://info.medtronicdiabetes.com/pump-placement Distributor Partner / Service Provider: Send existing patients the Patient Notification. To HCPs send the HCP Notification and Patient Notification
Quantity in commerce: 13,429
Distribution: Worldwide - US Nationwide distribution including in the states of OR, CA, AZ, NY,TX,FL, OH, MO, TN,NJ, NC, SC, IL, VA, WA, DC, GA, PA, MS,IA, MI, NH, OK, SD, MT, WI, WV, MA, LA, MN, RI, AR, ME, AL, IN, UT, KY, CO, ND, MD, CT, NM, KS, ID, NV, DE, NE, VT, AK, HI, WY, PR, VI and the countries of Taiwan, New Zealand, Australia, Bangladesh, Brunei Darussalam, Cambodia, Indonesia, Malaysia, Maldives, Philippines, Thailand, Vietnam, Singapore, Pakistan, Hong Kong, China, Argentina, Aruba, Barbados, Bermuda, Bolivia, Plurinational State Of, Brazil, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Honduras, Mexico, Panama, Paraguay, Peru, Puerto Rico, Trinidad And Tobago, Uruguay, Venezuela, Canada, South Korea, India, Albania, Algeria, Andorra, Armenia, Austria, Azerbaijan, Bahrain, Belarus, Belgium, Bosnia And Herzegovina, Botswana, Bulgaria, Canary Islands, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Faroe Islands, Finland, France, French Guyana, French Polynes., Georgia, Germany, Gibraltar, Greece, Guadeloupe, Hungary, Iceland, Iran, Iraq, Ireland, Israel, Italy, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Liechtenstein, Lithuania, Luxembourg, Macedonia, Malawi, Malta, Martinique, Mauritius, Mayotte, Moldavia, Montenegro, Morocco, Namibia, Netherlands, New Caledonia, Nigeria, Northern Ireland, Norway, Oman, Poland, Portugal, Qatar, Reunion, Romania, Russia, San Marino, Saudi Arabia, Serbia, Sierra Leone, Slovakia, Slovenia, South Africa, Spain, St.Pier,Miquel., Sudan, Sweden, Switzerland, Syrian Arab Republic, Tanzania, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Yemen, Zambia, Zimbabwe.
Product codes and lots: Pump: UDI-DI(GTIN): User Guide Name(Part-Version): MiniMed 530G: 00643169507784, 00643169736061, 00643169736092, 00643169736085, 00643169933224, 00763000161170: Artwork, CRB A Process, Instr, 530G, One Press, Launch, US(MP6026081-012DOC); Artwork, CRB A Process, Instr, 530G, FDA comments, add TST(MP6025813-013DOC); Artwork, CRB A Process, Instr, 530G, Remove Velcro, Icons, US(MP6025813-014DOC);

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1751-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1739-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-04-02
Z-1740-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-04-02
Z-1741-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-04-02
Z-1742-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-04-02
Z-1743-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-04-02
Z-1744-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-04-02
Z-1745-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-04-02
Z-1746-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-04-02
Z-1747-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-04-02
Z-1748-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-04-02
Z-1749-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-04-02
Z-1750-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-04-02
Z-1751-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-04-02
Z-1752-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-04-02

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)