Class 2 Device Recall Medtronic MiniMed 600 Series Insulin Pump Systems

• Date Initiated by Firm: September 20, 2022
• Date Posted: November 08, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0194-2023
• Recall Event ID: 90910
• Product Classification: Pump, infusion, insulin, to be used with invasive glucose sensor - Product Code OYC
• Product: Insulin Pump/Model:; MiniMed 620G/ MMT-1750; MiniMed 640G/ MMT-1711, MMT-1712, MMT-1751, MMT-1752
• Code Information: 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
• Recalling Firm/ Manufacturer: Medtronic MiniMed; 18000 Devonshire St; Northridge CA 91325-1219
• For Additional Information Contact: Medtronic 24-Hr Technical Support; 800-646-4633 Ext. 1
• Manufacturer 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.
• FDA Determined 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.