Recall Z-1635-2026— Medtronic MiniMed, Inc.

Name: FDA recall Z-1635-2026
Creator: U.S. Food and Drug Administration
Published: 2026-01-30

Class II · Ongoing

Class II FDA medical device recall by Medtronic MiniMed, Inc., initiated 2026-01-30. It names one FDA 510(k) clearance: K251032. Product: MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61. Reason: 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)..

Recalling firm: Medtronic MiniMed, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2026-01-30
Firm location: Northridge, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K251032 — MiniMed 780G insulin pumpMedtronic Minimed, Inc.·cleared 2025-07-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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, over-delivery, or cessation of delivery).

Data sourced from openFDA. This site is unofficial and independent of the FDA.