Medtronic MiniMed - Insulin Pump
Medtronic MiniMed is a leading manufacturer of insulin pumps and diabetes management solutions. Their products help patients with diabetes manage their condition effectively.
Lower-risk recall
Three software defects (Pump Error 53, BG check, and Critical Pump Error (Open Book Image)) that occurred as a result of software updates (versions 6.60, 6.61, and 6.62), which could result in a risk of hypoglycemia or hyperglycemia due to inaccuracies in insulin delivery (either under-delivery, over-delivery, or cessation of delivery).
Contact the company
What happened, in plain English
Medtronic MiniMed is a leading manufacturer of insulin pumps and diabetes management solutions. Their products help patients with diabetes manage their condition effectively. Read more at govinfonow.com/recall/50066-medtronic-minimed-insulin-pump.
Source Summary by GovInfoNow · govinfonow.com/recall/50066-medtronic-minimed-insulin-pump · Updated August 10, 2026 · FDA enforcement record: FDA #Z-1635-2026
Cite this page
“Medtronic MiniMed - Insulin Pump.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/50066-medtronic-minimed-insulin-pump. Based on FDA recall #Z-1635-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1635-2026%22&limit=1).
Why it’s dangerous
Insulin pumps are medical devices that deliver insulin to patients with diabetes. They are generally safe when used correctly, but improper use or malfunction can lead to health risks such as hypoglycemia or hyperglycemia.
Who’s affected
Patients with diabetes
How to tell if you have this one
Ensure the insulin pump is properly calibrated, the battery is charged, and the device is functioning correctly before use. Regularly check the pump's settings and the patient's blood glucose levels.
- Brand
Medtronic MiniMed- Category
Medical device
What to do — step by step
1
Verify the insulin pump is properly calibrated and the battery is charged.
2
Check the pump's settings and ensure they match the patient's diabetes management plan.
3
Monitor the patient's blood glucose levels regularly to detect any signs of hypoglycemia or hyperglycemia.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 50 states.
FDA distribution: “Worldwide - U.S. 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, RI, SC, SD, TN,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1635-2026 (January 30, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1635-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.