FDA (Devices) recall action 96200
The FDA (Devices) publishes a recall like this one as 12 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 12 pages.
All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to changes in air pressure, which can be found during airplane take-off or landing. An unexpected additional dose of insulin, which can occur during take-off, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An unexpected under-delivery of insulin, which can occur during landing, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to changes in air pressure, which can be found during airplane take-off or landing. An unexpected additional dose of insulin, which can occur during take-off, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An unexpected under-delivery of insulin, which can occur during landing, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death. During a delivery accuracy dry run testing …
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 is recalling MiniMed insulin pumps due to air pressure changes during airplane takeoff and landing that can cause abnormal insulin delivery. Overdoses risk severe hypoglycemia; underdoses risk severe hyperglycemia and diabetic ketoacidosis.
Medtronic MiniMed 720G insulin pumps may malfunction during airplane travel due to air pressure changes, causing abnormal insulin doses that can lead to severe low or high blood sugar emergencies.
Medtronic MiniMed's Paradigm insulin pumps can malfunction during airplane flight due to air pressure changes, potentially causing dangerously high or low blood sugar levels that could be fatal.
Medtronic MiniMed insulin pumps can deliver abnormal insulin doses during air pressure changes in airplane travel, risking severe hypoglycemia or hyperglycemia and serious complications.
Medtronic MiniMed insulin pumps may deliver abnormal doses of insulin during airplane takeoff or landing due to air pressure changes. This can result in severe hypoglycemia or hyperglycemia, with potential for seizure, coma, or death.
Medtronic MiniMed insulin pumps may deliver abnormally high or low insulin doses in response to air pressure changes during airplane takeoff and landing, potentially causing severe hypoglycemia or hyperglycemia.
Medtronic recalled MiniMed insulin pumps due to abnormal delivery caused by air pressure changes during airplane flights. The defect can cause severe hypoglycemia or hyperglycemia, potentially leading to seizure, coma, or death.
Medtronic MiniMed Paradigm insulin pumps may deliver incorrect insulin doses during airplane takeoff or landing due to air pressure changes. This can cause severe high or low blood sugar requiring immediate medical attention.
Medtronic is recalling MiniMed insulin pumps that malfunction during airplane takeoff and landing due to air pressure changes. The defect can cause abnormal insulin delivery, leading to severe hypoglycemia, hyperglycemia, seizure, coma, or death.
Medtronic MiniMed insulin pumps may deliver insulin abnormally during airplane take-off or landing due to air pressure changes, risking severe low or high blood sugar emergencies.
Medtronic MiniMed insulin pumps may deliver abnormal insulin doses during airplane takeoff or landing due to air pressure changes, potentially causing severe low or high blood sugar.
MiniMed insulin pumps may deliver abnormal insulin doses during aircraft takeoff and landing due to air pressure changes, risking severe blood sugar fluctuations, seizures, and potentially fatal complications.