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Insulin Pump/Model recallZ-0193-2023 · Medtronic MiniMed · initiated Sep 20, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic MiniMed or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Component change control

What the company is doing

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.

Recall details

Recall number
Z-0193-2023
Status
Open, Classified
Initiated by the company
Sep 20, 2022
Posted by the FDA
Nov 8, 2022
Recalling firm
Medtronic MiniMed
Quantity
399651
Product code
OZP
FDA submissions
P160017, P150001
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 description

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

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

Model/UDI-GTIN(All Serial Numbers): MMT-1715/643000000000, 763000072520, 643169873834, 00643169656840; MMT-1755/643169752726, 643169873841, 643169878648, 763000179632, 00643169752726; MMT-1754/643169976344; MMT-1780/643169949706, 643169939202, 763000072537, 643000000000, 00643169939219; MMT-1781/763000187415, 763000283568, 00763000140601, 00763000225575, 00763000235765, 00763000187415, 00763000283551, 00763000240707; MMT-1782/763000187422, 763000283599, 00763000140618, 00763000225612, 00763000235772, 00763000187422, 00643169957640, 00763000283582; MMT-1760/643169946040, 763000278427, 763000179649, 643169946057, 763000367084, 00643169946057; MMT-1761/00763000367657, 00763000165413; MMT-1762/00763000239404, 00763000203313, 00763000216481, 00763000187408, 00763000165475; MMT-1740/Investigational; MMT-1741/00763000303556, 00763000408916; MMT-1742/00763000250232

Devices named in this recall

15 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

80 devices cleared under P160017, P150001 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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