Medtronic MiniMed is a leading manufacturer of insulin pumps and diabetes management solutions. Their products help patients with diabetes manage their condition effectively.
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).
Medtronic MiniMed is a leading manufacturer of insulin pumps and diabetes management solutions. Their products help patients with diabetes manage their condition effectively.
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.
Patients with diabetes
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.
Verify the insulin pump is properly calibrated and the battery is charged.
Check the pump's settings and ensure they match the patient's diabetes management plan.
Monitor the patient's blood glucose levels regularly to detect any signs of hypoglycemia or hyperglycemia.
Medtronic MiniMed is a leading manufacturer of insulin pumps and diabetes management solutions. Their products help patients with diabetes manage their condition effectively.
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.
Improper use or malfunction of an insulin pump can lead to health risks such. As a result, it is important to follow the manufacturer's instructions and receive proper training.
We’ve drafted a message you can send Medtronic MiniMed to request your refund or repair — edit it as you like.
Subject: Recall Z-1635-2026 — Medtronic MiniMed Medtronic MiniMed Hello, I own a Medtronic MiniMed that is covered by recall Z-1635-2026 from Medtronic MiniMed. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.