PlainRecalls
FDA Devices Moderate Class II Ongoing

Insulin Pump/Model: MiniMed 620G/ MMT-1750 MiniMed 640G/ MMT-1711, MMT-1712, MMT-1751, MMT-1752

Reported: November 16, 2022 Initiated: September 20, 2022 #Z-0194-2023

Product Description

Insulin Pump/Model: MiniMed 620G/ MMT-1750 MiniMed 640G/ MMT-1711, MMT-1712, MMT-1751, MMT-1752

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.

Details

Recalling Firm
Medtronic MiniMed
Units Affected
316326
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
Location
Northridge, CA

Frequently Asked Questions

What product was recalled? ▼
Insulin Pump/Model: MiniMed 620G/ MMT-1750 MiniMed 640G/ MMT-1711, MMT-1712, MMT-1751, MMT-1752. Recalled by Medtronic MiniMed. Units affected: 316326.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 16, 2022. Severity: Moderate. Recall number: Z-0194-2023.

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