FDA (Devices) recall action 78125
The FDA (Devices) publishes a recall like this one as 5 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 5 pages.
Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin.
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 Mio infusion sets because they may over-deliver insulin. The recall covers 1,513,530 units distributed worldwide.
Medtronic is recalling MiniMed Silhouette infusion sets because they may over-deliver insulin. The recall covers 1,898,570 units distributed worldwide.
Medtronic is recalling Sure-T infusion sets because they may deliver too much insulin. This could cause low blood sugar in patients.
Medtronic is recalling MiniMed Quick-set infusion sets because they may deliver too much insulin. The recall covers 3,971,030 units distributed worldwide.
Medtronic is recalling 5,842 MiniMed Pro-set infusion sets worldwide due to a potential risk of over-delivering insulin.