# FDA recall Z-0193-2023

> **Medtronic MiniMed** · Class II · device recall initiated 2022-09-20.

## Product

Insulin Pump/Model:   MiniMed 630G/ MMT-1715, MMT-1755, MMT-1754;  MiniMed 670G/ MMT-1780, MMT-1781, MMT-1782, MMT-1760, MMT-1761, MMT-1762, MMT-1740, MMT-1741, MMT-1742

## Reason for recall

Medtronic identified a cybersecurity vulnerability in the MiniMed 600 series Insulin Pump Systems associated with the communication protocol that could allow unauthorized access to the pump system. This unauthorized access could be used to deliver too much or too little insulin through delivery of an unintended insulin bolus or because insulin delivery is slowed or stopped, which could lead to hypoglycemia or hyperglycemia.  The Remote Bolus feature on insulin pumps should be turned off to prevent the unauthorized access.

## Distribution

US: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, 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, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY.  OUS: Andorra, Australia, Austria, Barbados, Belgium, Bermuda, Bolivia, Botswana, Canada, Canary Islands, Cayman Islands, Chile, Czech Republic, Denmark, Dominican Rep., El Salvador, Faroe Islands, Finland, France, Germany, Gibraltar, Greece, Guatemala, Hungary, Ireland, Israel, Italy, Kenya, Liechtenstein, Luxembourg, Mauritius, Mexico, Namibia, Netherlands, New Zealand, Norway, Paraguay, Peru, Poland, Portugal, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, Trinidad and Tobago, Turkey, Uganda, United Kingdom, Venezuela

## Key facts

- **Recall number:** Z-0193-2023
- **Recalling firm:** Medtronic MiniMed
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-09-20
- **Report date:** 2022-11-16

- **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-0193-2023

## Citation

> AI Analytics. FDA recall Z-0193-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0193-2023. Source: US FDA. Licensed CC0.

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