Medtronic MiniMed 780G software defects may cause insulin delivery inaccuracies
Medtronic is recalling MiniMed 780G insulin pumps on software 6.60 and 6.61 because three software defects could result in hypoglycemia or hyperglycemia through inaccurate insulin delivery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: the source describes a risk of hypoglycemia or hyperglycemia from inaccurate insulin delivery, and no injuries are stated.
Plain-English summary
Medtronic MiniMed, Inc. is recalling the MiniMed 780G insulin pump, models MMT-1884 and MMT-1886, with software 6.60 and 6.61. About 26,851 pumps were distributed across the United States nationwide and to Israel. The FDA has classified this recall as Class II.
Three software defects — Pump Error 53, BG check, and Critical Pump Error (Open Book Image) — occurred as a result of software updates versions 6.60, 6.61 and 6.62. These could result in a risk of hypoglycemia or hyperglycemia due to inaccuracies in insulin delivery, either under-delivery, over-delivery, or cessation of delivery.
Affected pumps are listed by model number, UDI-DI and serial number in the FDA enforcement record.
Users and clinicians can identify affected pumps by the model number and software version above, and may contact Medtronic MiniMed, Inc. for further information.
The recalled product
- Product
- MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61
- Manufacturer
- Medtronic MiniMed, Inc.
- Category
- Medical Device — Insulin pump
- Affected units
- 26,851
Distribution
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