FDA (Devices) recall action 83433
The FDA (Devices) publishes a recall like this one as 16 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 16 pages.
The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect wirelessly to a nearby insulin pump to change settings and control insulin delivery.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Medtronic MiniMed is recalling 225,498 Paradigm insulin pumps due to cybersecurity vulnerabilities that could allow unauthorized wireless control of insulin delivery.
Medtronic MiniMed is recalling 34,777 Paradigm 512 insulin pumps due to potential cybersecurity vulnerabilities that could allow unauthorized wireless control of insulin delivery.
Medtronic MiniMed is recalling Paradigm Veo insulin pumps due to cybersecurity vulnerabilities that could allow unauthorized wireless control of insulin delivery.
Medtronic MiniMed is recalling 64,174 MiniMed Insulin Pumps (model MMT-508) due to potential cybersecurity vulnerabilities that could allow unauthorized wireless control of insulin delivery.
Medtronic MiniMed is recalling 74,496 MiniMed Paradigm Insulin pumps due to cybersecurity vulnerabilities that could allow unauthorized wireless control of insulin delivery.
Medtronic MiniMed is recalling 38 Paradigm insulin pumps due to cybersecurity vulnerabilities that could allow unauthorized wireless control of insulin delivery.
Medtronic MiniMed is recalling 17 Paradigm insulin pumps due to cybersecurity vulnerabilities that could allow unauthorized wireless control of insulin delivery.
Medtronic MiniMed is recalling 30,479 Paradigm Model 511 insulin pumps due to cybersecurity vulnerabilities that could allow unauthorized wireless control of insulin delivery.
Medtronic MiniMed is recalling 2,322 Paradigm Veo insulin pumps due to cybersecurity vulnerabilities that could allow unauthorized wireless control of insulin delivery.
Medtronic MiniMed is recalling 27 Paradigm insulin pumps due to a cybersecurity vulnerability that could allow unauthorized wireless control of insulin delivery.
Medtronic MiniMed is recalling 10 Paradigm insulin pumps due to cybersecurity vulnerabilities that could allow unauthorized wireless control of insulin delivery.
Medtronic MiniMed is recalling 73,028 Paradigm insulin pumps due to cybersecurity vulnerabilities that could allow unauthorized wireless control of insulin delivery.
Medtronic MiniMed is recalling 23,221 Paradigm insulin pumps due to cybersecurity vulnerabilities that could allow unauthorized wireless control of insulin delivery.
Medtronic MiniMed is recalling 88,243 Paradigm insulin pumps due to cybersecurity vulnerabilities that could allow unauthorized wireless control of insulin delivery.
Medtronic MiniMed is recalling 72,850 Paradigm insulin pumps due to cybersecurity vulnerabilities that could allow unauthorized wireless control of insulin delivery.
Medtronic MiniMed is recalling 36,143 Paradigm insulin pumps due to a cybersecurity vulnerability that could allow unauthorized wireless control of insulin delivery.