Medtronic MiniMed 780G Software Defect Recall - Hypoglycemia Risk
Summary
The FDA initiated Class II recall Z-1635-2026 for Medtronic MiniMed 780G insulin pumps (models MMT-1884, MMT-1886) with Software versions 6.60 and 6.61. Three software defects (Pump Error 53, BG check, and Critical Pump Error) may cause inaccurate insulin delivery, creating hypoglycemia or hyperglycemia risk. The recall affects devices distributed nationwide across all U.S. states and is ongoing.
What changed
Medtronic MiniMed 780G insulin pumps are subject to a Class II recall due to three software defects introduced in software updates (versions 6.60, 6.61, and 6.62). The defects—Pump Error 53, BG check issues, and Critical Pump Error (Open Book Image)—can cause inaccuracies in insulin delivery through either under-delivery or over-delivery, resulting in risk of hypoglycemia or hyperglycemia. Recall number is Z-1635-2026.
Healthcare providers managing patients using MiniMed 780G models MMT-1884 and MMT-1886 with Software 6.60 or 6.61 should identify affected devices in their patient population, notify patients of the hypoglycemia risk, and coordinate with Medtronic for software updates or device replacements. Patients should monitor blood glucose closely and contact Medtronic or their healthcare provider for guidance on managing their insulin therapy during the ongoing recall.
What to do next
- Identify patients using MiniMed 780G MMT-1884 or MMT-1886 with Software 6.60 or 6.61
- Notify affected patients of hypoglycemia/hyperglycemia risk from potential insulin delivery inaccuracies
- Coordinate with Medtronic for software corrections or device replacement per recall instructions
Archived snapshot
Apr 7, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Medtronic MiniMed, Inc.
Device Recalls (Class II)
← All Device Recalls (Class II) Class II Z-1635-2026 · 20260401 · Ongoing
Product
MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61
Reason for 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, ...
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,...
Source: openFDA Enforcement API
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