On October 5, 2021, Medtronic announced the expansion of two recalls on MiniMed 600 series insulin pumps for incorrect insulin dosing and remote controllers used with Paradigm and 508 MiniMed insulin pumps for potential cybersecurity risks. The U.S. Food and Drug Administration (FDA) has identified both of these as Class I recalls, the most serious type of recall.
People with diabetes who are currently using a MiniMed 600 series insulin pump and are unsure if their device is affected, should refer to the Medical Device Recalls database or use the Medtronic Pump Serial Number Look-up Tool. If you are using the MiniMed 508 insulin pump or the MiniMed Paradigm family of insulin pumps with a remote controller that is part of the expanded recall, you should immediately follow the FDA’s guidance on next steps.
Medtronic is recalling:
MiniMed™ 600 Series Insulin Pumps
• Model 630G - Distribution Dates: September 2016 to February 2020
• Model 670G - Distribution Dates: May 2015 to December 2020
All MiniMed Remote Controllers used with a Medtronic MiniMed 508 insulin pump or the MiniMed Paradigm family of insulin pumps
• Model MMT-500 and MMT-503 - Distribution Dates: August 1999 to July 2018
“We recognize that it can be frightening to learn about the recall of a device you depend on,” said Nicole Johnson, Vice President of Operations, Science and Health Care for the American Diabetes Association® (ADA). “If you must stop using your device, please contact your health care team immediately to discuss other insulin delivery protocols that will be right for you. Your health and safety are always top priority.”
If you feel anxious or need to talk to someone, you can find mental health professionals with diabetes knowledge in the ADA’s Mental Health Provider Directory. For more information on the Medtronic recalls and next steps, call Medtronic’s 24-Hour helpline at 1-800-378-2292 or visit the resources below:
• Medtronic Recalls MiniMed Insulin Pumps for Incorrect Insulin Dosing
• Medtronic Recalls Remote Controllers Used with Paradigm and 508 MiniMed Insulin Pumps for Potential Cybersecurity Risks
• Medtronic MiniMed™ Pump Retainer Ring Notice
• Medtronic MiniMed™ Remote Controller Notice
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About the American Diabetes Association
The American Diabetes Association (ADA) is the nation’s leading voluntary health organization fighting to bend the curve on the diabetes epidemic and help people living with diabetes thrive. For 81 years the ADA has driven discovery and research to treat, manage, and prevent diabetes while working relentlessly for a cure. Through advocacy, program development, and education we aim to improve the quality of life for the nearly 122 million Americans living with diabetes or prediabetes. Diabetes has brought us together. What we do next will make us Connected for Life. To learn more or to get involved, visit us at diabetes.org or call 1-800-DIABETES (1-800-342-2383). Join the fight with us on Facebook (American Diabetes Association), Spanish Facebook (Asociación Americana de la Diabetes), Twitter (@AmDiabetesAssn) and Instagram (@AmDiabetesAssn).