Z-0194-2023Class II

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

Name: Z-0194-2023 Insulin Pump/Model: MiniMed 620G/ MMT-1750 MiniMed 640G/ MMT-1711, MMT-1712, MMT-1751, MMT-1752
Creator: Medtronic MiniMed
Published: 2022-09-20
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2022-09-20 / Open, Classified / root cause: software

FDA source

Medtronic MiniMed began a recall of Insulin Pump/Model: MiniMed 620G/ MMT-1750 MiniMed 640G/ MMT-1711, MMT-1712, MMT-1751, MMT-1752 on 2022-09-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0194-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-09-20
Posted: 2022-11-08
Recalling firm: Medtronic, Inc.
Product: Insulin Pump/Model: MiniMed 620G/ MMT-1750 MiniMed 640G/ MMT-1711, MMT-1712, MMT-1751, MMT-1752
Product code: OYC Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
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.
Root cause tag: software
FDA root cause: Component change control
Action: On 09/20/2022, correction notices were distributed to customers, healthcare professionals, distributors, and service providers. They were informed to take the following actions: 1. Turn off the "Remote Bolus" feature on your pump if it is turned on. Note that the "Remote Bolus" capability is on by default, so take this action even if this feature has never been used. See Appendix: "How to Turn Off Remote Bolus Settings" or by visiting our website at www.medtronicdiabetes.com/remote-bolus 2. Conduct any connection linking of devices in a non-public place. 3. Complete and return the customer confirmation form. RECOMMENDED PRECAUTIONS: 1. Keep your pump and connected system components within your control at all times. 2. Be attentive to pump notifications, alarms, and alerts. 3. Immediately cancel any boluses you or your care partner did not initiate, monitor blood glucose levels closely and reach out to Medtronic 24-Hour Technical Support to report the bolus. NOTE: Turning off remote bolus feature will ensure no remote bolus is possible. 4. Disconnect the USB device from your computer when you're not using it to download pump data. 5. DO NOT confirm remote connection requests or any other remote action on the pump screen unless it is initiated by you or your care partner. 6. DO NOT share your pump's or devices' serial numbers with anyone other than your healthcare provider, distributors, and Medtronic. 7. DO NOT accept, calibrate, or bolus using a blood glucose reading you didn't initiate. 8. DO NOT connect to or allow any third-party devices to be connected to your pump 9. DO NOT use any software which has not been authorized by Medtronic as being safe for use with your pump. 10. Get medical help immediately when experiencing symptoms of severe hypoglycemia or diabetic ketoacidosis. 11. Call the recalling firm's 24-Hour Technical Support, 1-800-646-4633, option 1, if you suspect a pump setting or insulin delivery has changed unexpectedly, without your knowledge.
Quantity in commerce: 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
Product codes and lots: Model/UDI-GTIN (All Serial Numbers): MMT-1750/00763000375461, 00643169559745; MMT-1711/643169554931, 763000367039, 00643169890039, 00643169554917, 00643169629813, 00643169554924, 00643169554931, 00643169742062, 00763000013066, 00643169554948, 00643169554955, 00643169621954; MMT-1712/643169662612, 643169577701, 00763000205409, 00643169890046, 00643169577664, 00643169629820, 00643169577671, 00643169577688, 00763000155346, 00643169577695, 00643169577701, 00643169621961; MMT-1751/643169672239, 00643169574410, 00643169574427, 00643169574434, 00763000253288, 00643169574441, 00643169574458, 00643169643512, 00643169521155, 00643169521704, 00763000015596, 00643169520882, 00643169521421, 00643169521971; MMT-1752/763000192181, 00643169596368, 00643169596382, 00643169596405, 00763000318291, 00763000318307, 00643169596443, 00643169522305, 00643169521292, 00643169522381, 00643169521841, 00643169522268, 00643169521025, 00643169522343, 00643169521575, 00643169522114

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0194-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0193-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-16	2022-11-07
Z-0194-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-16	2022-11-07

Product code OYC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)