# FDA recall Z-1635-2026

> **Medtronic MiniMed, Inc.** · Class II · device recall initiated 2026-01-30.

## 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,  over-delivery, or cessation of 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, MD, ME, MI,  MN, MO, MS, MT, NC, ND, NE, NH,NJ,  NM, NV, NY, OH,OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the country of Israel.

## Key facts

- **Recall number:** Z-1635-2026
- **Recalling firm:** Medtronic MiniMed, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-01-30
- **Report date:** 2026-04-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Northridge, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1635-2026

## Citation

> AI Analytics. FDA recall Z-1635-2026. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1635-2026. Source: US FDA. Licensed CC0.

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